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The MedallionR lens five years later
the Medallion R lens five years later Robert C. Drews, M.D. St. Louis, Missouri ABSTRACT A retrospective review of90 cases of Medallion R lens implantation, all with at least a five-year follow-up, revealed a variety oflate complications, very few of which were directly related to the implantation or presence of an intraocular lens. Long-term progressive deterioration of nylon iris-lens sutures occurred, but late lens dislocations were not a problem, although two cases developed worrisome erosion through the sphincter into the iris stroma. Some of the earlier patients were those with a guarded prognosis; overall visual results would have improved had these cases been deleted.
Key words: Medallion intraocular lens, intracapsular cataract extraction, late complications, nylon sutures
The short-term results of intraocular lens (IOL) implantation are well established, especially by the recent preliminary report of the FDA study. 1 For some, the long-term results of lens implantation remain in question. A detailed study therefore was made of my own patients who had received lens implants more than five years ago.
SUBJECTS AND METHODS Systematic record-keeping and sequential numbering of implant cases made it easy to identify all patients who had received IOLs prior to March 5, 1975. There were a total of90 eyes; 11 patients had received lens implant surgery in both eyes. No patient record was eliminated from this study and this series represents a complete and consecutive surgical experience. The average age of the patients in this series was 71.9 years. Except for one infant, aged 18 months, and one woman, aged 49, all patients were between 52 and 90 years of age. All patients had intracapsular cataract extraction without a conjunctival flap and with three silk, modified track sutures. 2 Additional silk and/or collagen sutures were added after closure. Cataract delivery was performed with an erisiphake. The iris suture was of 10-0 nylon. Except for one patient who developed endophthalmitis, routine postoperative care consisted of chloramphenicol (Chloromycetin) drops twice a day and an antibiotic/steroid (Maxitrol) ointment twice a day for about one month. After these were discontinued, fluorometholone (FML) drops were used twice a day. FML was tapered and discontinued after the eye became quiet. Occasionally, FML drops were used for prolonged periods of time, sometimes prophylactically. No mydriatics were used in the postoperative care of any of these patients, even in the office.
All patients in this series received a standard power 20-diopter Worst iris suture Medallion R lens, manufactured by Medical Workshop and sterilized in sodium hydroxide. All IOLs used were of the usual configuration, except for one small-incision lens placed without an iris suture as a secondary implant. Routine visual field testing and many of the intraocular pressure measurements were done by office nurses and technicians. I performed all other tests and measurements, including visual acuities and refractions.
Length of Follow-up: Lost Cases This series consists of all patients operated on over five years ago. The longest follow-up was 6.6 years. The average follow-up was 5.7 years. The validity of a study such as this is easily negated if there are a significant number of patients who have been lost to follow-up. Considering that the average age of this group of patients was about 72 years, it is not surprising that 26 (29%) patients died. Three other cases were lost to follow-up. The average age of these three patients was 81 years, and their average follow-up time was 2.8 years. Two had visual acuities of 20/25 or better at the time of the last postoperative visit. RESULTS The postoperative records of study patients were summarized on the American Intra-Ocular Implant Society's Data Flow Sheets. Tabulation and analysis of the complications felt to be significant in the FDA intraocular lens investigation are listed below in the prescribed order. Patients were followed closely, and the number of postoperative visits far exceeded the FDA's minimum requirements.
Refraction The error of fitting all patients with a standard 20D IOL is reflected in the range of postoperative refract-
Reprint requests to Dr. Drews, 211 N. Meramec, Clayton, MO 63105. AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
49
ive errors (Fig. 1). The average of the absolute values of the refractive errors was 1. 93D. The range of postoperative refractive errors has since been significantly reduced, first by selecting a lens implant power based on the patient's precataractous refractive error,3 and subsequently by using A-scan ultrasound equipment. The average against-the-rule astigmatic error was 2.65D (Fig. 2), almost 2D larger than the average astigmatic error for patients undergoing routine cataract surgery without lens implantation. This discrepancy may be caused by factors involved in wound healing. 4 There were two patients in this series with 8D of cylinder postoperatively, one of whom fortunately improved to 2. 5D. The judicious use of postplaced nylon sutures now yields much better results.
No.ol Pationt.
VISUAL ACUITIES
~20/40 Initial-71eyes-79% Final- 59 eye.-66%
15
10
5
I 20/ 20/ 20/ 20/ 20/ 20/ 20/ 20/ 20/ 3/ 15 20 25 30 40 50 70 100 200 24
SPHERICAL EQUIVALENT
I
[All fit wittu 20 IOL I
1.... -0.95:1:2.32 Ab •. Ay.
t.G3
_-FlnaIVA III-Boot VA, not malntalnod
NO.of
}75
CF -Hm LP
I NLP
Fig. 3 (Drews). Visual acuities.
•• 1 .1. -8
-7
-e
-!I
-4
h.11I1111.1 111.1 .•.. -3
-2
_,
+2
+3
'5
DfOPURS
Fig. 1 (Drews). Spherical equivalent.
NO.of
CYLINDER
.~.
AV.2.65
.1 3
4
5
6
• •
Fig. 2 (Drews). Cylinder.
Visual Results Initially 79% of the eyes achieved 20/40 vision or better, however only 66% retained this visual acuity by the end of the study (Fig. 3). Reasons for final visual acuity less than 20/40 are listed in Table 1. This table includes eyes with similar diagnoses but better visual acuities. For example, of the 24 eyes with mac50
ular degeneration, 13 had 20/40 vision or better and only 11 had less than 20/40 vision at the end of this study. It was interesting to note that although the average age of patients with macular degeneration in this series was 4.7 years greater than the average age for the series as a whole, there was no difference in average age of patients whose macular degeneration was progressive (76.5 years) as compared to those who did not show progression of visual loss (76.6 years). Surprisingly, even though they constituted an older age group, only 17% of patients with macular degeneration died, as compared to 29% for the entire series.
Other Base Data All anterior chamber depths in this series were normal and no patient experienced anterior chamber shallowing during the early postoperative period. Corneal pachometry was not done. Elevated intraocular pressures occurred fairly frequently in the early postoperative course. In almost all instances pressure normalized after topical steroids were discontinued. None of the eyes were on topical steroids when study data were compiled, although I do not hesitate to use a mild topical steroid in any eye which shows evidence of lens precipitates. Adverse Reactions There were no cases of hypopyon or acute corneal decompensation. One patient developed endophthalmitis on the fourth postoperative day, but fortunately recovered with vigorous antibiotic therapy. He has some very peculiar deposits in the macula. Although he reads 20/25, he does so in a manner which suggests the presence of multiple tiny central scotomata. Eleven (12%) eyes required secondary surgical intervention, seven related to iris suture breakage with
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
corneal touch (4 eyes) or surgical repair of dislocation with McCannel suture (3 eyes). Three eyes underwent retinal detachment surgery. One physician with pre-existing early endothelial corneal dystrophy wanted lens implant surgery anyway, "in preparation for corneal graft if this becomes necessary." This patient did very well initially but later had decompensation of the cornea which required grafting. Recently this graft has begun to cloud. With the exception of one retinal detachment surgery, all secondary operations were associated with a good visual result.
Postoperative Complications In general these IOL patients did not have a crystal-clear cornea 24 hours after surgery, as seen in most of my patients undergoing cataract extraction without lens implantation. However, all corneas cleared nicely. Clearing was delayed in the eye with preoperative corneal dystrophy and in another eye which healed slowly with edema of the upper cornea and 8D of persistent cylinder. There was no significant iritis in any eye and chronic mild inflammation was not a problem. Posterior synechiae were very unusual. Other Complications There were no hyphemas and no wound problems: no wound leaks, no flat anterior chambers, no fistulas, no blebs, and no pupillary block. (These figures are not zero since then.) There were no patients with an atonic pupil. Either macular edema was rare, or missed. One referred patient developed cystoid macular edema (CME) six years after surgery, with reduction of visual acuity to 20170. This was part of an intermittent touch syndrome; the offending broken nylon iris suture which had also caused a localized corneal dystrophy was removed, the cornea and macula improved, and vision is now 20/20. One patient with chronic CME developed macular scarring and loss of central vision. The only other patient in the group identified as having macular edema never had less than 20/40 visual acuity and currently has 20/20 vision. Two patients have received medications for control of intraocular pressure. Neither of these patients has lost field and neither shows any cupping of the disc. The four patients with retinal detachment fall into two categories. Two patients had retinal detachments which are presumed to have been present before cataract removal. Both of these patients had dense cataracts preventing a view of the fundus and neither was studied with B-scan ultrasound preoperatively. In both cases retinal detachment was discovered immediately after cataract surgery. Retinal repair was attempted in one case, however the other case was judged to be inoperable because of massive periretinal proliferation. Neither eye achieved central vi-
sion. Two patients developed retinal detachment postoperatively (Table 1). Both of them did very well after corrective surgery and both currently have a visual acuity of 20/25. Two patients developed retinal vascular occlusions (Table 1). One of these recovered 20/25 visual acuity. The other went on to light perception but did not develop rubeosis. Two patients had optic atrophy, presumably ischemic (Table 1). Three patients had preexisting glaucomatous optic atrophy, two with extremely advanced glaucoma, tiny central visual fields, and a preoperative visual acuity of light perception (Table 1). Postoperatively these two patients had no light perception, even though intraocular pressures were never out of control. Gonioscopy was not routinely done on the patients in this series. The patients who were gonioscoped showed a remarkable absence of peripheral anterior synechiae (G. Lowe, M.D., and R.c. Drews, M.D., unpublished data, April 1980). There were few notes of detachment of Descemet's membrane; however, recent experience, especially with gonioscopy, has shown that minor localized scrolls of Descemet's are not rare. One patient developed a cyclitic membrane: An 18-month-old infant had bilateral congenital cataracts. Thc zonular cataract in one eyc was managed with an optical iridectomy. The complete cataract in the second cye was aspirated. A rapidly forming secondary membranc in this eye was needled twice, and a secondary lens implant was then perform cd for optical correetion and in the hope of maintaining the needle opening. The recurrent "secondary membrane" was eventually diagnosed as fibrous downgrowth. Although the patient began using the eye almost at once after implant surgery and looked quite well for a time, fibrous down growth recurred and encapsulated the IOL, finally producing a cyclitic membrane with phthisis and no light perception.
In no case had an IOL been placed after vitreous loss. Only one eye had subsequent herniation of vitreous into the anterior chamber and no eye showed evidence of vitreous adherence to the wound. One patient had a small foreign body on the IOL, unobserved until the vitreous abcess radiating from it and the endophthalmitis cleared. No patient in this series developed clinical evidence of a choroidal detachment.
Intraocular Lens Complications Lens precipitates were not unusual in minor degrees. There were no problems with heavy precipitates. All lenses had been sterilized with sodium hydroxide. None of the lenses in this series were malpositioned. Three lenses dislocated repeatedly (Table 2).
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
51
Late dislocations were unusual. Slight notching of the pupil margin was not unusual, however two such cases developed worrisome erosion through the sphincter into the iris stroma.
Table 2. Lens dislocations. Number of Case No. Dislocations
Table 1. Reasons for visual acuity less than 20/40. Numbers in parentheses refer to those eyes with the same diagnosis but better visual acuities. Final Visual Acuity Diagnosis
20/15 20/30 20/50 20/100 3124 -20/25 -20/40 -20170 -20/200 -1175
Macular degeneration
(7)
Optic atrophy Open-angle glaucoma (preoperative)
(6)
4
(1)
1
CF -LP
NLP
1
1
2
3
Secondary glaucoma
(2)
o
Retinal detachment
(2)
o 1
1
Corneal dystrophy
o
26 months 34 months 37 months
(no suturesmall incision lens used)
59
2
20 days 3 months
intact
62
2
24 months 25 months
intact
I had previously reported an incidence of nylon suture breakage of about 5%,·5 based on 300 eyes with a follow-up of six months to three years. The pattern of nylon suture breakage in the present series is graphed in Figs. 4 and 5. The rate of suture breakage appears to level off at about 30%. No eye required miotics to maintain IOL position, although five eyes had surgery either to correct a suture end which was annoying the cornea, or to place a McCannel suture prophylactically.
No.of
n= 24 (27%)
EYES
av =3.4 years
4
3
Corneal dystrophy (preoperative)
1
Failed graft
1
Diabetic retinopathy
2*
1 1
1 1
1 (1)
1
2*
1
Vitreous hemorrhage (preoperative)
1
Macular scar (preoperative)
1
1
Cerebral vascular accident
1
1
1
2
Fibrous ingrowths
1
1*
Epithelial down growth
1
1*
Unknown cause
1
Total number of cases
9
I
2
Retinal vascular (1) occlusion
1* 3
13
2
4
31
Related to surgery 7*
52
3
BROKEN NYLON SUTURES
Retinal detachment (preoperative)
Cystoid macular edema
Condition of Suture
58
Total No. of Cases
11
6
1
Postoperative Times
I. 2
3
4
5
• 6
YEARS
Fig. 4 (Drews). Broken nylon sutures.
Touch of the cornea by the IOL did not occur in this group. The Medallion lens was chosen partly because it does not have loops in the anterior chamber to threaten peripheral cornea. Other diagnoses are listed in Table 1. Patients receiving IOLs early in the study sometimes included those with a very guarded visual prognosis. There were two disastrous cases. One was the infant discussed above. This eye however would have been phthisical without IOL implantation and there is no evidence that the IOL hastened or otherwise adversely affected the outcome. In fact, it was only after the IOL was placed that it was possible to maintain a pupil at all. A second patient developed epithelial down growth three years after surgery, which progressed to absolute glaucoma and no light perception. This patient subsequently lost the eye when he struck it on an overturned bedstead, rupturing the globe.
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7. JANUARY 1981
%NYLON SUTURES BROKEN 100" at 12 yr
30"
/
l
20
10
2
3
4
5
6
edema accounting only for central visual loss in an eye which was a museum of pathology otherwise. The other patient, discussed earlier, improved after the cause of CME was recognized and corrected. One patient, now over 95 years old, developed a retinal vascular occlusion. Another much younger patient developed both intraocular and intracranial hemorrhages and lost both his vision and his reason. One patient developed epithelial down growth three years after surgery. Six patients had significantly progressive macular degeneration in the years after surgery. In only one case could delayed visual loss be ascribed to the iris suture IOL. Indeed, most of these pseudophakic eyes looked excellent. Table 3. Reasons for delayed loss of vision.
YEARS --Raw data
·········Corr.ct.d for no. of .y •• follow.d
Fig. 5 (D rews). This figure graphs the breakage of nylon sutures as a percent of the total number of sutures in the eye. If breakage continued at the same rate that it did between the second and fourth years, one would predict that 40% of the sutures would be broken by the sixth year, and that 100% of the sutures would he broken by year 12. Instead , the curve tends to level off at less than a 30% breakage rate. The dotted line shows the same data recalculated for the subgroup of 30 patients who were followed for more than six years. Note that the curve does not rise with this recalculation. (This douhle plot also gives some feeling for th e imprecision of the conclusions .)
DISCUSSION Th e results of this series speak for themselves. More adroit selection of patients for lens implant surgery would have resulted in a higher percentage of good visual results. Poor central retinal function is considered one of the indications for lens implant surgery. My experience echoes that of others in these cases: most patients were overjoyed with regain ed peripheral vision. Indeed, this was the first time that patients with such poor prognoses were so happ y postoperatively. Many of these patients were referred by colleagues reluctant to operate themselves, although they felt cataract surgery was indicated. Although it is easy to pick out surgical causes for decreased visual acuity, very few of these eyes had a poor visual result attributable to the implantation or presence of an IOL. A careful analysis was done of those eyes experiencing delayed visual loss (Table 3) . Three eyes undergoing a combined procedure of cataract extraction, lens implantation and keratoplasty experienced late graft failure. Of the two patients with CME, one was an extremely complex case with the cystoid macular
Case Age , in Number years
Visual Acuity Initial
Final
Diagnosis
22
61
20170
3/48
Failed graft
76
73
20/20
20/100 Failed graft
51
72
20/20
20/200 Failed graft
30
75
20/25
3/30
85
49
20/20
20170
31
90
20/20
CF
Retinal vascular occlusion
83
67
20170
LP
Intraocular and intracranial hemorrhages
87
63
20/40
NLP
CME (Plus) C~E
(6 years post-op)
Epithelial downgrowth
20
72
20/25
20170
23
73
20/15
3/30
33
74
20/20
52
84
20/25
3/38
Macular degeneration
57
74
20/25
2/38
Macular degeneration
89
82
20/50
3/48
Macular degeneration
~acular
degene ration
Macular dege neration
20/200 Macular degene ration
The absence of IOL problems in these eyes does not guarantee that such problems cannot develop in the future, however it is very encouraging that the results so far are so free of late IOL-induced problems. The only evidence for possible future concern is the Significant progressive tearing of the iris, beginning as pupil margin erosion and now extending beyond the sphincter and into the iris stroma. This has only been seen in two eyes, neither of which has had any problems . In one case a prophylactic McCannel suture was placed; hop efu ll y, decreasing the degree of pseudophakodonesis in this eye will halt progression of the rent or prevent IOL dislocation if the rent does progress furth er.
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
53
CONCLUSION A careful retrospective study of90 consecutive eyes which received Medallion intraocular lens implants over five years ago has shown a number of postoperative problems, very few of which were related to the intraocular lens. The absence of late, lens-related intraocular problems speaks eloquently in favor of the two-loop iris suture Medallion lens design of Jan Worst. It seems that those who learn to use this lens safely can be reassured of very few long-term problems for their patients. 6 REFERENCES 1. Worthen DM, Boucher JA, Buxton IN et al: Interim FDA re-
2. Drews RC: A modified double-track suturc technique. Ophthalmic Surg 10:46, 1979 3. Drews RC: Programs for the HP-25/C calculators for lens implant power. Am Intra-Ocular Implant Soc} 3:2, 1977 4. Drews RC: The role of the iris in the healing of corneal wounds (thesis). Trans Am Ophthalmol Soc 77:422, 1980 5. Drews RC: Complications of modern surgical procedures: (Intraocular lenses): Inflammatory response, endophthalmitis, corneal dystrophy, glaucoma, retinal detachment, dislocation, refractive error, lens removal and enucleation. Ophthalmol 85:164, 1978 6. Worst JGF, Mosselman CD, Ludwig HH: The artificial lens experience with 2000 lens implantations. Am Intra-Ocular Implant Soc} 3:14, 1977
port on intraocular lenses. Ophthalmol 87:267, 1980
54
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
Key words: Medallion intraocular lens, intracapsular cataract extraction, late complications, nylon sutures
The short-term results of intraocular lens (IOL) implantation are well established, especially by the recent preliminary report of the FDA study. 1 For some, the long-term results of lens implantation remain in question. A detailed study therefore was made of my own patients who had received lens implants more than five years ago.
SUBJECTS AND METHODS Systematic record-keeping and sequential numbering of implant cases made it easy to identify all patients who had received IOLs prior to March 5, 1975. There were a total of90 eyes; 11 patients had received lens implant surgery in both eyes. No patient record was eliminated from this study and this series represents a complete and consecutive surgical experience. The average age of the patients in this series was 71.9 years. Except for one infant, aged 18 months, and one woman, aged 49, all patients were between 52 and 90 years of age. All patients had intracapsular cataract extraction without a conjunctival flap and with three silk, modified track sutures. 2 Additional silk and/or collagen sutures were added after closure. Cataract delivery was performed with an erisiphake. The iris suture was of 10-0 nylon. Except for one patient who developed endophthalmitis, routine postoperative care consisted of chloramphenicol (Chloromycetin) drops twice a day and an antibiotic/steroid (Maxitrol) ointment twice a day for about one month. After these were discontinued, fluorometholone (FML) drops were used twice a day. FML was tapered and discontinued after the eye became quiet. Occasionally, FML drops were used for prolonged periods of time, sometimes prophylactically. No mydriatics were used in the postoperative care of any of these patients, even in the office.
All patients in this series received a standard power 20-diopter Worst iris suture Medallion R lens, manufactured by Medical Workshop and sterilized in sodium hydroxide. All IOLs used were of the usual configuration, except for one small-incision lens placed without an iris suture as a secondary implant. Routine visual field testing and many of the intraocular pressure measurements were done by office nurses and technicians. I performed all other tests and measurements, including visual acuities and refractions.
Length of Follow-up: Lost Cases This series consists of all patients operated on over five years ago. The longest follow-up was 6.6 years. The average follow-up was 5.7 years. The validity of a study such as this is easily negated if there are a significant number of patients who have been lost to follow-up. Considering that the average age of this group of patients was about 72 years, it is not surprising that 26 (29%) patients died. Three other cases were lost to follow-up. The average age of these three patients was 81 years, and their average follow-up time was 2.8 years. Two had visual acuities of 20/25 or better at the time of the last postoperative visit. RESULTS The postoperative records of study patients were summarized on the American Intra-Ocular Implant Society's Data Flow Sheets. Tabulation and analysis of the complications felt to be significant in the FDA intraocular lens investigation are listed below in the prescribed order. Patients were followed closely, and the number of postoperative visits far exceeded the FDA's minimum requirements.
Refraction The error of fitting all patients with a standard 20D IOL is reflected in the range of postoperative refract-
Reprint requests to Dr. Drews, 211 N. Meramec, Clayton, MO 63105. AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
49
ive errors (Fig. 1). The average of the absolute values of the refractive errors was 1. 93D. The range of postoperative refractive errors has since been significantly reduced, first by selecting a lens implant power based on the patient's precataractous refractive error,3 and subsequently by using A-scan ultrasound equipment. The average against-the-rule astigmatic error was 2.65D (Fig. 2), almost 2D larger than the average astigmatic error for patients undergoing routine cataract surgery without lens implantation. This discrepancy may be caused by factors involved in wound healing. 4 There were two patients in this series with 8D of cylinder postoperatively, one of whom fortunately improved to 2. 5D. The judicious use of postplaced nylon sutures now yields much better results.
No.ol Pationt.
VISUAL ACUITIES
~20/40 Initial-71eyes-79% Final- 59 eye.-66%
15
10
5
I 20/ 20/ 20/ 20/ 20/ 20/ 20/ 20/ 20/ 3/ 15 20 25 30 40 50 70 100 200 24
SPHERICAL EQUIVALENT
I
[All fit wittu 20 IOL I
1.... -0.95:1:2.32 Ab •. Ay.
t.G3
_-FlnaIVA III-Boot VA, not malntalnod
NO.of
}75
CF -Hm LP
I NLP
Fig. 3 (Drews). Visual acuities.
•• 1 .1. -8
-7
-e
-!I
-4
h.11I1111.1 111.1 .•.. -3
-2
_,
+2
+3
'5
DfOPURS
Fig. 1 (Drews). Spherical equivalent.
NO.of
CYLINDER
.~.
AV.2.65
.1 3
4
5
6
• •
Fig. 2 (Drews). Cylinder.
Visual Results Initially 79% of the eyes achieved 20/40 vision or better, however only 66% retained this visual acuity by the end of the study (Fig. 3). Reasons for final visual acuity less than 20/40 are listed in Table 1. This table includes eyes with similar diagnoses but better visual acuities. For example, of the 24 eyes with mac50
ular degeneration, 13 had 20/40 vision or better and only 11 had less than 20/40 vision at the end of this study. It was interesting to note that although the average age of patients with macular degeneration in this series was 4.7 years greater than the average age for the series as a whole, there was no difference in average age of patients whose macular degeneration was progressive (76.5 years) as compared to those who did not show progression of visual loss (76.6 years). Surprisingly, even though they constituted an older age group, only 17% of patients with macular degeneration died, as compared to 29% for the entire series.
Other Base Data All anterior chamber depths in this series were normal and no patient experienced anterior chamber shallowing during the early postoperative period. Corneal pachometry was not done. Elevated intraocular pressures occurred fairly frequently in the early postoperative course. In almost all instances pressure normalized after topical steroids were discontinued. None of the eyes were on topical steroids when study data were compiled, although I do not hesitate to use a mild topical steroid in any eye which shows evidence of lens precipitates. Adverse Reactions There were no cases of hypopyon or acute corneal decompensation. One patient developed endophthalmitis on the fourth postoperative day, but fortunately recovered with vigorous antibiotic therapy. He has some very peculiar deposits in the macula. Although he reads 20/25, he does so in a manner which suggests the presence of multiple tiny central scotomata. Eleven (12%) eyes required secondary surgical intervention, seven related to iris suture breakage with
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
corneal touch (4 eyes) or surgical repair of dislocation with McCannel suture (3 eyes). Three eyes underwent retinal detachment surgery. One physician with pre-existing early endothelial corneal dystrophy wanted lens implant surgery anyway, "in preparation for corneal graft if this becomes necessary." This patient did very well initially but later had decompensation of the cornea which required grafting. Recently this graft has begun to cloud. With the exception of one retinal detachment surgery, all secondary operations were associated with a good visual result.
Postoperative Complications In general these IOL patients did not have a crystal-clear cornea 24 hours after surgery, as seen in most of my patients undergoing cataract extraction without lens implantation. However, all corneas cleared nicely. Clearing was delayed in the eye with preoperative corneal dystrophy and in another eye which healed slowly with edema of the upper cornea and 8D of persistent cylinder. There was no significant iritis in any eye and chronic mild inflammation was not a problem. Posterior synechiae were very unusual. Other Complications There were no hyphemas and no wound problems: no wound leaks, no flat anterior chambers, no fistulas, no blebs, and no pupillary block. (These figures are not zero since then.) There were no patients with an atonic pupil. Either macular edema was rare, or missed. One referred patient developed cystoid macular edema (CME) six years after surgery, with reduction of visual acuity to 20170. This was part of an intermittent touch syndrome; the offending broken nylon iris suture which had also caused a localized corneal dystrophy was removed, the cornea and macula improved, and vision is now 20/20. One patient with chronic CME developed macular scarring and loss of central vision. The only other patient in the group identified as having macular edema never had less than 20/40 visual acuity and currently has 20/20 vision. Two patients have received medications for control of intraocular pressure. Neither of these patients has lost field and neither shows any cupping of the disc. The four patients with retinal detachment fall into two categories. Two patients had retinal detachments which are presumed to have been present before cataract removal. Both of these patients had dense cataracts preventing a view of the fundus and neither was studied with B-scan ultrasound preoperatively. In both cases retinal detachment was discovered immediately after cataract surgery. Retinal repair was attempted in one case, however the other case was judged to be inoperable because of massive periretinal proliferation. Neither eye achieved central vi-
sion. Two patients developed retinal detachment postoperatively (Table 1). Both of them did very well after corrective surgery and both currently have a visual acuity of 20/25. Two patients developed retinal vascular occlusions (Table 1). One of these recovered 20/25 visual acuity. The other went on to light perception but did not develop rubeosis. Two patients had optic atrophy, presumably ischemic (Table 1). Three patients had preexisting glaucomatous optic atrophy, two with extremely advanced glaucoma, tiny central visual fields, and a preoperative visual acuity of light perception (Table 1). Postoperatively these two patients had no light perception, even though intraocular pressures were never out of control. Gonioscopy was not routinely done on the patients in this series. The patients who were gonioscoped showed a remarkable absence of peripheral anterior synechiae (G. Lowe, M.D., and R.c. Drews, M.D., unpublished data, April 1980). There were few notes of detachment of Descemet's membrane; however, recent experience, especially with gonioscopy, has shown that minor localized scrolls of Descemet's are not rare. One patient developed a cyclitic membrane: An 18-month-old infant had bilateral congenital cataracts. Thc zonular cataract in one eyc was managed with an optical iridectomy. The complete cataract in the second cye was aspirated. A rapidly forming secondary membranc in this eye was needled twice, and a secondary lens implant was then perform cd for optical correetion and in the hope of maintaining the needle opening. The recurrent "secondary membrane" was eventually diagnosed as fibrous downgrowth. Although the patient began using the eye almost at once after implant surgery and looked quite well for a time, fibrous down growth recurred and encapsulated the IOL, finally producing a cyclitic membrane with phthisis and no light perception.
In no case had an IOL been placed after vitreous loss. Only one eye had subsequent herniation of vitreous into the anterior chamber and no eye showed evidence of vitreous adherence to the wound. One patient had a small foreign body on the IOL, unobserved until the vitreous abcess radiating from it and the endophthalmitis cleared. No patient in this series developed clinical evidence of a choroidal detachment.
Intraocular Lens Complications Lens precipitates were not unusual in minor degrees. There were no problems with heavy precipitates. All lenses had been sterilized with sodium hydroxide. None of the lenses in this series were malpositioned. Three lenses dislocated repeatedly (Table 2).
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981
51
Late dislocations were unusual. Slight notching of the pupil margin was not unusual, however two such cases developed worrisome erosion through the sphincter into the iris stroma.
Table 2. Lens dislocations. Number of Case No. Dislocations
Table 1. Reasons for visual acuity less than 20/40. Numbers in parentheses refer to those eyes with the same diagnosis but better visual acuities. Final Visual Acuity Diagnosis
20/15 20/30 20/50 20/100 3124 -20/25 -20/40 -20170 -20/200 -1175
Macular degeneration
(7)
Optic atrophy Open-angle glaucoma (preoperative)
(6)
4
(1)
1
CF -LP
NLP
1
1
2
3
Secondary glaucoma
(2)
o
Retinal detachment
(2)
o 1
1
Corneal dystrophy
o
26 months 34 months 37 months
(no suturesmall incision lens used)
59
2
20 days 3 months
intact
62
2
24 months 25 months
intact
I had previously reported an incidence of nylon suture breakage of about 5%,·5 based on 300 eyes with a follow-up of six months to three years. The pattern of nylon suture breakage in the present series is graphed in Figs. 4 and 5. The rate of suture breakage appears to level off at about 30%. No eye required miotics to maintain IOL position, although five eyes had surgery either to correct a suture end which was annoying the cornea, or to place a McCannel suture prophylactically.
No.of
n= 24 (27%)
EYES
av =3.4 years
4
3
Corneal dystrophy (preoperative)
1
Failed graft
1
Diabetic retinopathy
2*
1 1
1 1
1 (1)
1
2*
1
Vitreous hemorrhage (preoperative)
1
Macular scar (preoperative)
1
1
Cerebral vascular accident
1
1
1
2
Fibrous ingrowths
1
1*
Epithelial down growth
1
1*
Unknown cause
1
Total number of cases
9
I
2
Retinal vascular (1) occlusion
1* 3
13
2
4
31
Related to surgery 7*
52
3
BROKEN NYLON SUTURES
Retinal detachment (preoperative)
Cystoid macular edema
Condition of Suture
58
Total No. of Cases
11
6
1
Postoperative Times
I. 2
3
4
5
• 6
YEARS
Fig. 4 (Drews). Broken nylon sutures.
Touch of the cornea by the IOL did not occur in this group. The Medallion lens was chosen partly because it does not have loops in the anterior chamber to threaten peripheral cornea. Other diagnoses are listed in Table 1. Patients receiving IOLs early in the study sometimes included those with a very guarded visual prognosis. There were two disastrous cases. One was the infant discussed above. This eye however would have been phthisical without IOL implantation and there is no evidence that the IOL hastened or otherwise adversely affected the outcome. In fact, it was only after the IOL was placed that it was possible to maintain a pupil at all. A second patient developed epithelial down growth three years after surgery, which progressed to absolute glaucoma and no light perception. This patient subsequently lost the eye when he struck it on an overturned bedstead, rupturing the globe.
AM INTRA-OCULAR IMPLANT SOC J-VOL. 7. JANUARY 1981
%NYLON SUTURES BROKEN 100" at 12 yr
30"
/
l
20
10
2
3
4
5
6
edema accounting only for central visual loss in an eye which was a museum of pathology otherwise. The other patient, discussed earlier, improved after the cause of CME was recognized and corrected. One patient, now over 95 years old, developed a retinal vascular occlusion. Another much younger patient developed both intraocular and intracranial hemorrhages and lost both his vision and his reason. One patient developed epithelial down growth three years after surgery. Six patients had significantly progressive macular degeneration in the years after surgery. In only one case could delayed visual loss be ascribed to the iris suture IOL. Indeed, most of these pseudophakic eyes looked excellent. Table 3. Reasons for delayed loss of vision.
YEARS --Raw data
·········Corr.ct.d for no. of .y •• follow.d
Fig. 5 (D rews). This figure graphs the breakage of nylon sutures as a percent of the total number of sutures in the eye. If breakage continued at the same rate that it did between the second and fourth years, one would predict that 40% of the sutures would be broken by the sixth year, and that 100% of the sutures would he broken by year 12. Instead , the curve tends to level off at less than a 30% breakage rate. The dotted line shows the same data recalculated for the subgroup of 30 patients who were followed for more than six years. Note that the curve does not rise with this recalculation. (This douhle plot also gives some feeling for th e imprecision of the conclusions .)
DISCUSSION Th e results of this series speak for themselves. More adroit selection of patients for lens implant surgery would have resulted in a higher percentage of good visual results. Poor central retinal function is considered one of the indications for lens implant surgery. My experience echoes that of others in these cases: most patients were overjoyed with regain ed peripheral vision. Indeed, this was the first time that patients with such poor prognoses were so happ y postoperatively. Many of these patients were referred by colleagues reluctant to operate themselves, although they felt cataract surgery was indicated. Although it is easy to pick out surgical causes for decreased visual acuity, very few of these eyes had a poor visual result attributable to the implantation or presence of an IOL. A careful analysis was done of those eyes experiencing delayed visual loss (Table 3) . Three eyes undergoing a combined procedure of cataract extraction, lens implantation and keratoplasty experienced late graft failure. Of the two patients with CME, one was an extremely complex case with the cystoid macular
Case Age , in Number years
Visual Acuity Initial
Final
Diagnosis
22
61
20170
3/48
Failed graft
76
73
20/20
20/100 Failed graft
51
72
20/20
20/200 Failed graft
30
75
20/25
3/30
85
49
20/20
20170
31
90
20/20
CF
Retinal vascular occlusion
83
67
20170
LP
Intraocular and intracranial hemorrhages
87
63
20/40
NLP
CME (Plus) C~E
(6 years post-op)
Epithelial downgrowth
20
72
20/25
20170
23
73
20/15
3/30
33
74
20/20
52
84
20/25
3/38
Macular degeneration
57
74
20/25
2/38
Macular degeneration
89
82
20/50
3/48
Macular degeneration
~acular
degene ration
Macular dege neration
20/200 Macular degene ration
The absence of IOL problems in these eyes does not guarantee that such problems cannot develop in the future, however it is very encouraging that the results so far are so free of late IOL-induced problems. The only evidence for possible future concern is the Significant progressive tearing of the iris, beginning as pupil margin erosion and now extending beyond the sphincter and into the iris stroma. This has only been seen in two eyes, neither of which has had any problems . In one case a prophylactic McCannel suture was placed; hop efu ll y, decreasing the degree of pseudophakodonesis in this eye will halt progression of the rent or prevent IOL dislocation if the rent does progress furth er.
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CONCLUSION A careful retrospective study of90 consecutive eyes which received Medallion intraocular lens implants over five years ago has shown a number of postoperative problems, very few of which were related to the intraocular lens. The absence of late, lens-related intraocular problems speaks eloquently in favor of the two-loop iris suture Medallion lens design of Jan Worst. It seems that those who learn to use this lens safely can be reassured of very few long-term problems for their patients. 6 REFERENCES 1. Worthen DM, Boucher JA, Buxton IN et al: Interim FDA re-
2. Drews RC: A modified double-track suturc technique. Ophthalmic Surg 10:46, 1979 3. Drews RC: Programs for the HP-25/C calculators for lens implant power. Am Intra-Ocular Implant Soc} 3:2, 1977 4. Drews RC: The role of the iris in the healing of corneal wounds (thesis). Trans Am Ophthalmol Soc 77:422, 1980 5. Drews RC: Complications of modern surgical procedures: (Intraocular lenses): Inflammatory response, endophthalmitis, corneal dystrophy, glaucoma, retinal detachment, dislocation, refractive error, lens removal and enucleation. Ophthalmol 85:164, 1978 6. Worst JGF, Mosselman CD, Ludwig HH: The artificial lens experience with 2000 lens implantations. Am Intra-Ocular Implant Soc} 3:14, 1977
port on intraocular lenses. Ophthalmol 87:267, 1980
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AM INTRA-OCULAR IMPLANT SOC J-VOL. 7, JANUARY 1981