Outcomes and complications associated with giant retinal tear management using perfluoro-n-octane

Outcomes and Complications Associated with Giant Retinal Tear Management Using Perfluoro-n-octane Ingrid U. Scott, MD, MPH, Timothy G. Murray, MD, Harry W. Flynn, Jr., MD, William J. Feuer, MS, Joyce C. Schiffman, MS, and the Perfluoron Study Group Objective: To report visual acuity and anatomic outcomes, as well as complications, associated with giant retinal tear management using intraoperative perfluoro-n-octane and to investigate clinical features associated with anatomic and visual acuity outcomes. Design: A prospective, noncomparative, observational, multicenter study. Participants: Two hundred twelve patients (212 eyes) ⱖ15 months of age who underwent giant retinal tear management with intraoperative perfluoro-n-octane at 24 study sites between April 1994 and February 1996. Giant retinal tear was defined as a retinal tear extending ⱖ90°. Intervention: Vitrectomy with perfluoro-n-octane intraoperative retinal tamponade. Main Outcome Measures: Visual acuity and rates of retinal reattachment, reoperation, retained perfluoron-octane, corneal edema, elevated intraocular pressure (IOP ⬎ 25 mmHg), hypotony (IOP ⬍ 5 mmHg), and cataract. All outcome measures were assessed at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively and at the last examination. Results: The study included 212 eyes of 212 patients followed a median of 3.5 months. Visual acuity ⱖ20/200 was measured in 56 (27%) patients preoperatively and 67 (47%) patients at 6 months. Postoperative visual acuity improved in 107 (59%) eyes, remained stable in 44 (24%) eyes, and worsened in 29 (16%) eyes (percentages are based on the number of patients for whom the data were available at these time points). Of the 124 patients with visual acuity ⱕ5/200 preoperatively, 94 (76%) had improved visual acuity at 6 months postoperatively. At 6 months, the retina was attached in 108 (76%) eyes, and retained perfluoro-n-octane was noted in 8 (6%) eyes. Throughout follow-up, 64 (30%) eyes underwent reoperation for recurrent retinal detachment. At 6 months, corneal edema, elevated IOP, and hypotony were noted in 5 (4%), 4 (3%), and 12 (9%) eyes, respectively. Of the 72 phakic eyes without cataract preoperatively, 61 (85%) had a cataract or underwent cataract extraction during study follow-up. Factors significantly (P ⬍ 0.05) associated with recurrent retinal detachment include female gender, younger age, preoperative proliferative vitreoretinopathy, prior vitrectomy, larger size of giant retinal tear, lack of scleral buckle placement, and relaxing retinotomy. Multivariate analysis demonstrated that female gender, larger size of giant retinal tear, and prior vitrectomy were significantly associated with recurrent detachment. Factors significantly associated with vision ⱖ20/200 include male gender, no prior vitrectomy, better preoperative vision, and no need for relaxing retinotomy. After adjusting for recurrent detachment, factors significantly associated with vision ⱖ20/200 include no prior vitrectomy, better preoperative vision, and no need for relaxing retinotomy. Conclusions: Retinal reattachment and preserved visual acuity were achieved in most eyes that underwent giant retinal tear management with intraoperative perfluoro-n-octane. Significant risk factors for recurrent retinal detachment include size of retinal tear, age, prior vitrectomy, and female gender. After adjusting for recurrent detachment, significant predictors of postoperative vision ⱖ20/200 include no prior vitrectomy, better preoperative vision, and no need for relaxing retinotomy. Ophthalmology 2002;109:1828 –1833 © 2002 by the American Academy of Ophthalmology. Historically, the management of retinal detachment associated with giant retinal tear has represented a challenge to Originally received: August 1, 2001. Accepted: March 1, 2002. Manuscript no. 210688. From the Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida. Supported in part by Research to Prevent Blindness, Inc., New York, New York, and a grant from Alcon, Inc., Fort Worth, Texas. Reprint requests to Ingrid U. Scott, MD, MPH, Bascom Palmer Eye Institute, PO Box 016880, Miami, FL 33101.

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© 2002 by the American Academy of Ophthalmology Published by Elsevier Science Inc.

vitreoretinal surgeons. Management strategies have included rapid head movements to unfold the retinal tear,1 fluid– gas exchange with the patient in the prone position,2– 6 manipulation of the retinal flap under silicone oil,7–10 intraoperative fixation of the retinal flap using retinal microincarceration,11,12 adhesives,13 sodium hyaluronate,14 –20 retinal tacks,21–23 screws,24 and sutures.25–27 Perfluorocarbon liquids have gained wide acceptance as intraoperative tools that simplify vitreoretinal surgical maneuvers in the repair of giant retinal tears. Because the specific gravity of perfluorocarbon liquid is 1.7 to 2.03 ISSN 0161-6420/02/$–see front matter PII S0161-6420(02)01184-3

Scott et al 䡠 Giant Retinal Tear/Perfluoro-n-octane Table 1. Baseline Characteristics (n ⫽ 212) Mean (SD) age, years Median (range) Gender, No. (%) Male Female Missing Race, No (%) Asian Black White Hispanic Missing Mean (SD) follow-up (mos) Median (range) Operated eye, No. (%) Right Left Mean (SD) IOP Median (range) IOP ⬎25 mmHg, No. (%) IOP ⬍5 mmHg, No. (%) Visual acuity, No. (%) ⱖ20/80 ⬍20/80–20/200 20/400 5/200–counting fingers Hand motions, light perception No light perception Lens status, No. (%) Phakic/clear Phakic/cataract Aphakic Intraocular lens Proliferative vitreoretinopathy, No. (%) Diabetes mellitus, No. (%) Yes No Missing Prior retinal detachment, No. (%) Yes No Missing Prior scleral buckling procedure, No. (%) Prior vitrectomy, No. (%) History of uveitis, No. (%)

41 (20) 44 (1–78) 160 47 5

with intraoperative perfluorocarbon liquid and was designed to report visual acuity and anatomic outcomes, as well as complications, and to investigate clinical features associated with outcomes.

(76) (22) (2)

5 (2) 20 (9) 122 (58) 26 (12) 39 (18) 3.8 (2.6) 3.5 (1–9) 118 (56) 94 (44) 12 (7) 12 (0–34) 8 (4) 6 (3) 43 13 10 49 91 1

(21) (6) (5) (24) (44) (1)

73 45 38 50 81

(35) (22) (18) (24) (38)

17 168 27

(8) (79) (13)

53 157 2 41 47 13

(25) (74) (1) (19) (22) (6)

IOP ⫽ intraocular pressure; SD ⫽ standard deviation.

times greater than that of water, this group of liquids may be used to displace subretinal fluid and blood anteriorly (thereby often avoiding the need to create a retinotomy for posterior drainage), to provide countertraction and retinal stabilization during membrane peeling, and to unfold the retina in giant retinal tear cases. Although several studies report the usefulness of perfluorocarbon liquids in the management of giant retinal tear, the number of eyes included in each of these reports ranges from only 1 to 42,28 –39 except for one series reporting 146 eyes in which intraoperative perfluoroperhydrophenanthrene (Vitreon, Vitrophage Inc., Lyons, IL) was used.40 In addition, prognostic factors associated with visual acuity outcomes were investigated in only the latter study.40 The current study represents the largest reported series of patients with giant retinal tears managed

Materials and Methods The study protocol was approved by the institutional review board at each of the participating centers. The study population consisted of patients 15 months of age and older who underwent giant retinal tear management with intraoperative perfluoro-n-octane (Perfluoron, Alcon, Inc., Fort Worth, TX) between April 1994 and February 1996. Giant retinal tear was defined as a retinal tear extending ⱖ90°. Patients were recruited as part of a multicenter national study and treated at 1 of 24 investigation sites by individual investigator-surgeons who had completed fellowship training in vitreoretinal surgery (Appendix A). The range of patient enrollment across centers was 3 to 32 patients. Individual study investigators at the study sites selected patients with giant retinal tear for participation in the study. Similar patients not selected for use of perfluoro-n-octane were not included in the study, and data on outcomes are not available for comparison. Because eyes with giant retinal tear secondary to trauma often have coexisting ocular injuries that portend a poor prognosis, eyes with traumatic giant retinal tears were excluded from this study. Outcome variables included visual acuity, rates of retinal reattachment, need for reoperation, retained perfluoro-n-octane, and rates of the following complications: corneal edema, elevated intraocular pressure (IOP ⬎25 mmHg), hypotony (IOP ⬍5 mmHg), and cataract. Outcome variable data were collected at study follow-up examinations, which were performed on postoperative day 1, and at week 1, month 1, month 3, and month 6. Best-corrected Snellen visual acuity was recorded during all study visits. When reporting the results at specific time points, percentages are based on the number of patients for whom data were available at each respective time points. The need for reoperation and the presence or absence of corneal edema and cataract were determined by the individual treating physician without a standardized study protocol. All study data from preoperative, operative, and postoperative forms were obtained from Alcon, Inc. (Fort Worth, TX) in a Table 2. Intraoperative Data Mean (SD) extent of giant retinal tear, degrees Median (range) Mean (SD) duration of surgery, min Median (range) Procedures in addition to vitrectomy, No. (%) Scleral buckling procedure Lensectomy Posterior retinotomy Relaxing retinotomy Penetrating keratoplasty Intraocular lens removal Intraocular tamponade, No. (%) Air SF6 C3F8 Silicone oil

166 (68) 163 (90–360) 173 (63) 160 (70–375) 131 72 20 39 4 3

(62) (34) (9) (18) (2) (1)

3 14 121 71

(1) (7) (57) (34)

SD ⫽ standard deviation.

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Ophthalmology Volume 109, Number 10, October 2002 Table 3. Postoperative Outcomes by Visit

N* Visual acuity (%) ⱖ20/80 20/81–200 20/201–20/400 20/401–CF HM, LP NLP Retina attached (%) Retained PFO (%) Corneal edema (%) IOP, mm Hg Mean (SD) (range) IOP ⬎25 (%) IOP ⬍5 (%)

1 Month

3 Months

6 Months

Last Follow-up

1 Day

1 Week

149

184

176

169

141

212

1 (1) 1 (1) 4 (3) 33 (23) 105 (72) 1 (1) 142 (95) 7 (5) 8 (5)

8 (4) 15 (8) 16 (9) 58 (32) 86 (47) 1 (1) 176 (93) 8 (4) 10 (5)

47 (27) 29 (17) 21 (12) 41 (23) 38 (22) 0 141 (80) 12 (7) 10 (6)

51 (30) 29 (17) 24 (14) 31 (18) 31 (18) 3 (2) 137 (79) 14 (8) 11 (6)

47 (33) 20 (14) 24 (17) 21 (15) 27 (19) 2 (1) 108 (76) 8 (6) 5 (4)

72 (35) 32 (15) 28 (14) 32 (15) 39 (19) 5 (2) 167 (79) 17 (8) 8 (4)

23 (11) (5–60) 48 (38) 0

19 (8) (5–55) 30 (17) 0

15 (8) (3–60) 12 (6) 6 (4)

13 (5) (0–34) 5 (3) 10 (6)

14 (6) (0–32) 4 (3) 12 (9)

14 (5) (1–33) 6 (3) 10 (5)

* N (number of patients) may not apply to all variables listed; for each variable percents are based on the total number of patients with recorded data. CF ⫽ counting fingers; HM ⫽ hand motions; IOP ⫽ intraocular pressure; LP ⫽ light perception; NLP ⫽ no light perception; PFO ⫽ perfluoron; SD ⫽ standard deviation.

paradox database and converted to SPSS (SPSS Inc., Chicago, IL) files with DBMSCOPY, and patients with a diagnosis of giant retinal tear were selected for study. Postoperative data were specifically collected at 1 day, 1 week, 1 month, 3 months, and 6 months follow-up, but any additional longer-term follow-up data that were available were also analyzed. Only one eye per patient was enrolled in the study. Visual outcome was defined as the central acuity at the last (6-month) study visit; if the patient missed the 6-month visit, the 3-month study visit acuity was used. Visual acuity data were available for 141 patients at 6 months and for 43 patients at 3 months; neither 3-month nor 6-month acuity information was available for 28 patients (13%), and these patients were excluded from visual acuity outcome analyses. For all variables, percentages in tables and text are of nonmissing data and may not always be based on the entire study group. Summary statistics were calculated for baseline and operative data and for outcome variables at each follow-up visit; these variables included visual acuity, retinal reattachment, corneal edema, IOP, and cataract. To identify factors prognostic for recurrent retinal detachment, Kaplan-Meier survival analysis was performed on the time to recurrent retinal detachment. The log-rank test was used to evaluate statistical significance. Cox proportional hazards model survival regression was used to perform multivariate analysis. Logistic regression was used to study risk factors for visual outcome ⱖ 20/200.

Results Demographic and baseline characteristics are summarized in Table 1. The study included 212 eyes of 212 patients followed for a median of 3.5 months. Proliferative vitreoretinopathy was noted preoperatively in 81 (38%) patients; 53 (25%) patients had a history of prior retinal detachment, and 47 (22%) patients had undergone a prior vitrectomy. Intraoperative data are summarized in Table 2. The giant retinal tear was 90° in extent in 24 (14%) patients, greater than 90° in 152 (86%) patients, and greater than 180° in 41 (23%) patients (this information was unavailable for 36 eyes). A scleral buckling

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procedure was performed in 131 (62%) patients, and a relaxing retinotomy was performed in 39 (18%) patients. Retinal slippage was noted intraoperatively in 33 (16%) patients, and iatrogenic retinal breaks were reported in 15 (7%) patients. Postoperative outcomes are displayed by study visit in Table 3. A visual acuity of 20/200 or better was measured in 56 (27%) patients preoperatively and 67 (47%) patients 6 months postoperatively. Postoperative visual acuity improved in 107 (59%) eyes, remained stable in 44 (24%) eyes, and worsened in 29 (16%) eyes. Of the 124 patients with visual acuity ⱕ5/200 preoperatively, 94 (76%) had improved visual acuity at 6 months postoperatively. At the 6-month postoperative visit, the retina was attached in 108 (76%) eyes, retained perfluoro-n-octane was noted in 8 (6%) eyes, and the number of eyes with corneal edema, elevated IOP, and hypotony were 5 (4%), 4 (3%), and 12 (9%) eyes, respectively. Of the phakic eyes without cataract preoperatively, 61 (85%) had a cataract or had undergone cataract extraction during the study follow-up interval. Of 45 phakic eyes with cataract preoperatively, 38 (84%) underwent cataract extraction during study follow-up. Retained perfluoro-n-octane was noted at any time during follow-up in 24 (11%) eyes; retained perfluoro-n-octane was not a significant predictor of either recurrent retinal detachment or visual outcome. Of 71 eyes with silicone oil tamponade, 42 (59%) had the oil removed during the study follow-up period. Expressed as a cumulative percentage (Kaplan-Meier analysis), 40% and 68% had silicone oil removed by 3 and 6 months, respectively. Tables 4 and 5 summarize the results of Kaplan-Meier survival analyses of preoperative and intraoperative characteristics with regard to recurrent retinal detachment. Characteristics significantly associated with recurrent retinal detachment include female gender, younger age, preoperative proliferative vitreoretinopathy, prior vitrectomy, larger size (in degrees) of giant retinal tear, lack of scleral buckle placement (either before study surgery or during study surgery), and creation of a relaxing retinotomy. Multivariate analysis of preoperative and intraoperative factors (Table 6) demonstrated that female gender, larger size of giant retinal tear, and prior vitrectomy were significantly associated with recurrent retinal detachment. Prior retinal detachment was not a univariately (Table 4) or multivariately (Table 6) significant predictor of recurrent retinal detachment after surgery with perfluoro-n-octane.

Scott et al 䡠 Giant Retinal Tear/Perfluoro-n-octane Table 4. Preoperative Characteristics Associated with Recurrent Retinal Detachment: Kaplan-Meier Survival Analysis

Table 5. Intraoperative Characteristics Associated with Recurrent Retinal Detachment: Kaplan-Meier Survival Analysis

Cumulative Proportion with Recurrent Retinal Detachment Variable

1 month

3 months

6 months

All subjects Gender Male Female Age group 1–30 yrs 31–50 yrs 51–78 yrs Race White Black Hispanic Asian Diabetes No Yes Preoperative PVR No Yes Previous RD No Yes Lens status Phakic Aphakic Pseudo Cataract Prior uveitis No Yes Prior scleral buckle No Yes Prior Vitrectomy No Yes

0.13

0.28

0.36

0.12 0.17

0.24 0.45

0.30 0.61

0.17 0.14 0.09

0.45 0.22 0.21

0.56 0.26 0.30

0.12 0.16 0.12 0.00

0.28 0.21 0.16 0.25

0.38 0.21 0.23 0.25

0.12 0.18

0.25 0.33

0.34 0.33

0.09 0.18

0.20 0.41

0.27 0.50

0.12 0.15

0.25 0.37

0.31 0.49

0.13 0.14 0.12 0.11

0.26 0.41 0.19 0.31

0.35 0.50 0.29 0.34

0.13 0.08

0.28 0.33

0.35 0.51

0.12 0.15

0.26 0.37

0.31 0.53

P Value* 0.0007 0.0005

0.81

0.98 0.002 0.092 0.39

0.20 0.067

Cumulative Proportion with Recurrent Retinal Detachment Variable

1 month

3 months

6 months

All subjects Eye OD OS Tear size 90–120° 121–180° 181–360° Scleral buckle No Yes Relaxing retinotomy No Yes Posterior retinotomy No Yes Tamponade None reported Oil C3F8 SF6 Retinal slippage No Yes Iatrogenic breaks No Yes

0.13

0.28

0.36

0.09 0.17

0.24 0.33

0.33 0.39

0.07 0.09 0.22

0.16 0.24 0.49

0.25 0.33 0.56

0.18 0.10

0.39 0.22

0.50 0.28

0.11 0.21

0.23 0.52

0.30 0.62

0.13 0.10

0.28 0.26

0.35 0.50

0.56 0.14 0.09 0.15

0.78 0.38 0.20 0.26

0.78 0.45 0.30 0.26

0.14 0.06

0.29 0.25

0.36 0.36

0.12 0.20

0.28 0.27

0.36 0.39

P Value* 0.25 0.0008

0.006 0.0001 0.60 0.0001

0.88 0.68

* Log-rank test. OD ⫽ right eye; OS ⫽ left eye.

0.0005 0.11 0.17

0.22 0.48

0.30 0.58

* Log-rank test. PVR ⫽ proliferative vitreoretinopathy; RD ⫽ retinal detachment.

Factors significantly associated with visual outcome of 20/200 or better include male gender, no prior vitrectomy, better preoperative vision, and no need for relaxing retinotomy intraoperatively. After adjusting for recurrent retinal detachment, factors significantly associated with a visual outcome of 20/200 or better include no prior vitrectomy, better preoperative vision, and no need for relaxing retinotomy.

Discussion Perfluorocarbon liquids serve as useful intraoperative tools during vitreoretinal surgery to unfold the retina in giant retinal tear cases and to provide countertraction and retinal stabilization during membrane peeling.29,32,34,40 –50 In the one other published study reporting prognostic factors associated with visual acuity outcomes after management of giant retinal tears using intraoperative perfluorocarbon liq-

uid, the perfluorocarbon liquid used was perfluoroperhydrophenanthrene (Vitreon), and factors significantly associated with a poor visual outcome (“poor” was not defined in the latter study) included hypotony, macular detachment, history of cataract extraction, poor preoperative visual acuity, giant retinal tear greater than 180°, and a higher grade of proliferative vitreoretinopathy.40 Factors prognostic of recurrent retinal detachment were not evaluated in the latter study, but in this study they included retinal tear size, prior vitrectomy, younger age, and female gender. After adjusting for recurrent retinal detachment, factors significantly associated with visual outcome of 20/200 or better include no prior vitrectomy, better preoperative vision, and no need for a relaxing retinotomy. In the study using Vitreon,40 all eyes were followed at least 6 months, and recurrent retinal detachment occurred in 80 (50%) eyes, 91% of retinas were attached at final follow-up, and visual acuity improved or remained stable in 65% eyes. In this study, the lower rate of recurrent retinal detachment (30%) and higher percentage of eyes with stable or improved visual acuity (84%) may be due to shorter follow-up of some eyes. In both studies, intraoperative perfluorocarbon liquid was demonstrated to be a safe and useful adjunct to pars plana vitrectomy in the management of giant retinal tears; retinal reattachment and preserved or improved visual acuity were achieved in most eyes.

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Ophthalmology Volume 109, Number 10, October 2002 Table 6. Multivariate Analysis of Predictors of Recurrent Retinal Detachment

Preoperative factors Variable Female gender (vs. male) Age group 1–30 yrs 31–50 yrs (vs. 51–78 yrs) Prior vitrectomy (vs. none) Intraoperative factors Size of tear 121–180° 181–360° (vs. 5–120°) Tamponade None reported Oil SF6 (vs. C3F8) Preoperative and intraoperative factors Female gender (vs. male) Size of tear 121–180° 181–360° (vs. 90–120°) Prior vitrectomy (vs. none)

Coefficient (Standard Error)

P Value

Risk Ratio (95% Confidence Interval)

1.02 (0.26)

⬍0.001

2.8 (1.7, 4.6)

0.008 0.81 (0.29) 0.01 (0.32) 0.73 (0.26)

2.2 (1.3, 4.0) 1.0 (0.5, 1.9) 0.007

2.1 (1.2, 3.5)

0.007 0.21 (0.34) 1.05 (0.36)

1.2 (0.6, 2.4) 2.9 (1.4, 5.8) 0.064

2.22 (0.75) 0.45 (0.29) 0.48 (0.56)

1.24 (0.29)

9.2 (2.1,40.0) 1.6 (0.9, 2.8) 1.6 (0.5, 4.8)

⬍0.001

3.5 (2.0, 6.1)

0.010 0.15 (0.34) 0.99 (0.35) 1.06 (0.29)

1.2 (0.6, 2.3) 2.7 (1.4, 5.3) 0.001

2.9 (1.6, 5.1)

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Scott et al 䡠 Giant Retinal Tear/Perfluoro-n-octane

34.

35.

36. 37. 38. 39. 40.

41. 42. 43. 44. 45. 46.

47.

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Appendix A Perfluoron Multicenter Clinical Trial Participating Institution Associated Retinal Consultants Royal Oak, Michigan Bascom Palmer Eye Institute Miami, Florida Baylor College of Medicine Houston, Texas California Pacific Medical Center San Francisco, California Candler Memorial Hospital Savannah, Georgia Cleveland Clinic Cleveland, Ohio Columbia University New York, New York Dean McGee Eye Institute Oklahoma City, Oklahoma Duke Eye Center Durham, North Carolina Emory University Atlanta, Georgia Healthsouth Hospital Birmingham, Alabama Illinois Retina Associates Harvey, Illinois Jules Stein Eye InstituteUCLA Los Angeles, California Mass Eye & Ear Infirmary Boston, Massachusetts Medical College of Wisconsin Milwaukee, Wisconsin New York Hospital New York, New York Oregon Health Services Portland, Oregon Penn State Medical Center Hershey, Pennsylvania Porter Memorial Hospital Denver, Colorado Stanford Medical Center Palo Alto, California St. Joseph’s Hospital Baltimore, Maryland St. Luke’s Hospital Chesterfield, Missouri Texas Retina Associates Dallas, Texas Wilmer Eye Institute Baltimore, Maryland

Principal Investigator George A. Williams, MD Timothy G. Murray, MD Michael H. Lambert, MD Wayne Fung, MD Joseph J. Scuderi, MD Hilel Lewis, MD Stanley Chang, MD Regan Bradford, MD Brooks McCuen, MD Thomas M. Aaberg, MD Robert Morris, MD Kirk Packo, MD Allan E. Kreiger, MD Donald J. D’Amico, MD Dennis Han, MD D. Jackson Coleman, MD Joe Robertson, MD George Blankenship, MD Jack Zilas, MD Mark S. Blumenkranz, MD Bert M. Glaser, MD M. Gilbert Grand, MD William L. Hutton, MD Julia A. Haller, MD

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