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Review of the American Intra-Ocular Implant Society Meeting
REVIEW OF THE AMERICAN INTRA-OCULAR IMPLANT SOCIETY MEETING KENNETH J. HOFFER, MD SANTA MONICA, CALIFORNIA THIS was an important year for the American Intra-Ocular Implant Society with its growing pains subsiding, the preparations for the Food and Drug Administration (FDA) investigation of lenses, and the recent upsurge in the use of and problems with anterior chamber lenses. This year's meeting, its third scientific session, relied heavily on presentations concerning anterior chamber lens difficulties. It was held on Oct 2, 1977, at the DallasHilton Hotel and was attended by an estimated 1,200 Academy participants. Dr Kenneth Hoffer, chairing this year's meeting, opened the session and called for presentation of the Honorary Memberships. This year's recipients were Dr Edward Epstein of South Africa for his original concept of the iris plane lens and Mr D. Peter Choyce of England for his intrepid pursuit of a safe anterior chamber implant. Dr Henry Hirschman cited these men for their work and presented their certificates. They join Ridley, Binkhorst, Fyodorov, and Reese as honorary members. The morning session was devoted to presentation of original papers. The first, by Dr Miles Galin, was one of several regarding the effect of lens implantation on endothelial cell counts, a subject of increasing interest and importance to anterior segment surgeons. Dr Galin re-
Submitted for publication Dec 8, 1977. Presented at the American Intra-Ocula r Implant Society Meeting, Dallas, Oct 2, 1977.
ported an overall cell reduction of 30% to 35% with all lens implantations, compared to 5% to 15% with routine cataract extraction. His studies have shown a six-fold increase of cell loss with implants over glaucoma procedures caused by the amount of implant endothelial touch at the time of insertion. He strongly urged the insertion of lenses in a closed-eye system with an air-filled formed chamber. Dr Alan Sugar reported a study by Dr Manus Kraff indicating that cell loss increases with the difficulty of the operation. Dr Edward Fetherolf, the 1977 Implant Society Fellow, concluded the report with his work in the development of an animal model, the adult cat, - for endothelial studies. Initial work shows a 7 % loss with simple cataract incision, 10% with incision and air injection, 8% loss with a Choyce lens implant, and a 40% loss after dislocation of an iris clip lens. His studies will continue.
Dr Cornelius Binkhorst emphasized the value of studying the endothelium and cited his paper in the 1972 TRANSACTIONS regarding graphs of cell vitality in relation to cell counts. He also emphasized that corneal dystrophy is the major long-term cause for angle-fixation failure. He cited a 38% increase in cell loss with intracapsular implant vs extracapsular implants and a 50% difference observed in both eyes of the same patient. He warned that long-term safety has not been proved with angle-fixated lenses
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and lenses used with phacoemulsification. Dr John Sheets offered a somber note of warning against the impulse to reinvent lens designs, modify previously abandoned and present designs, and use newer, untried materials and techniques without protocols to prove their safety. Dr Kenneth Hoffer reported the results of the use of 70,000 lenses by 734 surgeons, stating the fact that 73% started implants in 1975 and 1976. The Medallion, iris clip, and iridocapsular lenses accounted for 50% of those used, and 61% of those were of European manufacture. He noted 4% secondary implants by one third of the surgeons. The overall visual result, 20/ 40 or better, was 83.8% with a 0.8% removal rate. Dr Richard Keates reported his examination of 12 Surgidev Choyce Mark VIII lenses removed from eyes with the syndrome of uveitis, glaucoma, and hyphema. Sharp and rough edges were found, with poor edge finish causing shearing of the iris stroma. Dr Robert Drews demonstrated the warping of footplates and electron microscopy of saw-like edge finishes on the Surgidev Mark VIII and also showed where the burr edges had embedded in the iris. He also documented degradation of 9-0 nylon, Supramid, and platinum-iridium loops in inflamed eyes with electron microscopy (EM) photographs. The morning session was interrupted by Dr Jaffe to make a surprise presentation of appreciation to Dr Hoffer for his work in the Society and in warning surgeons about defective or contaminated lenses. The meeting continued with
391
an excellent presentation of pathologic evaluation of eyes containing intraocular lenses by Dr John Wright of the Armed Forces Institute of Pathology. The salient aspects were the complete lack of foreign body reaction to polymethylmethacrylate (PMMA), and the EM studies of a lens in an eye for 19 years which showed no change in the PMMA. Atrophy and necrosis of pupillary borders was noted as well as iris pigment dispersal and high attenuation of endothelial cells. David Link, the Director of the FDA Bureau of Medical Devices, presented the history, purpose, and future of FDA involvement in intraocular lenses. He stated that their effectiveness was not in question. Daniel Seigel of the National Eye Institute presented the plans for large randomized controlled studies. The morning session ended with the presentation of the third Binkhorst Medal Lecture by Dr Norman S. Jaffe. It was the highlight of the meeting. For the first time an age-matched retrospective study of 500 patients with and 500 patients without lenses was presented in great detail. The overall results were the same in both groups. The salient features are so important, that the paper should be read in its entirety by all ophthalmologists. Dr Jaffe also presented his tenyear experience with lens implants, compared the Copeland and iris clip lenses, and demonstrated a five-fold increase in cystoid macular edema with intracapsular implants vs extracapsular after one year. Dr Binkhorst presented the Binkhorst Medal to Dr Jaffe with these
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KENNETH J. HOFFER
words, "It is said that the light of the world comes from two sources, the sun and the student's lamp. The sun is certainly abundant in Miami, and the lamp of Norman Jaffe has contributed much to the science of intraocular lenses." Dr Jaffe accepted the medal and stated that this was his greatest professional honor in his 31 years as a physician. The afternoon session was devoted entirely to a symposium on the recent problems with Choyce lenses. Dr Jaffe moderated the panel based on his lack of bias and experience with this lens. Dr Robert Azar outlined the possible causes of the uveitis-glaucomahyphema syndrome as: the origin of the PMMA (Perspex CQ vs Rohm & Haas), the method of molding, quality control, surgical judgment, errors in surgical technique, and patient predisposition. He reported removing 6 of 27 Surgidev lenses and none of the 800 Rayner lenses. Dr Thomas Ellingson, who initially described this syndrome with Choyce lenses, reported removing 5 of 11 Surgidev and one McGhan. He recommended the use of polarized light to inspect the lens for internal stress. Dr Joseph Giovinco reported no cases of this syndrome in the 168 Rayner lenses he had implanted since 1970. Dr John Corboy demonstrated the physical difference between injectionmolded Rohm & Haas and handlathed Perspex CQ lenses, in that the former shrivel and warp with high temperatures, while the latter are more resistant. Dr Henry Hirschman reported four cases of the syndrome with 16 Surgidev lenses and stressed that patients experience pain on touching the
OPHTH AAOO
eye with the anterior chamber lenses. Dr John Sheets reported a lower overall success rate with anterior chamber lenses of all manufacturers as compared with his use of other lens styles. Dr Richard Kratz stressed the shaving effect of the lens on the iris in 2 out of 17 Surgidev lenses he removed. Drs Norman Stahl and Stephen Obstbaum reported on the gonioscopic aspects of anterior chamber lenses. Dr Obstbaum stressed that torque forces occurring in entering the proximal feet can dislocate previously accurate distal feet. Dr Jerald Tennant mentioned the importance of quality control in these lenses and pointed out that all previous triangular designs caused a high incidence of corneal dystrophy, noting the Kelman lens. Dr Richard Keates pointed out that of the lenses he reported on earlier, 14 were Surgidev and one was McGhan. Dr William McReynolds introduced a new instrument for direct internal measurement of anterior chamber length. He also reported that 3% of the lenses he checked for dioptric power showed a two to nine diopter variance from that labeled. Dr Arthur Hurt reported 86 primary cases with Rayner lenses over 18 months with no occurrence of the syndrome. The symposium was concluded by Mr D. Peter Choyce who categorized anterior chamber lenses according to manufacturer. Type A were Rayner Perspex CQ hand-lathed, polished, and sterilized by caustic soda (on which his 14 years experience are based). Type B lenses were the same but gas sterilized, while Type C were Rohm & Haas injection molded, gas sterilized lenses. He reported the syndrome with one Surgidev and one McGhan lens and recom-
VOLUME 85 APRIL 1978
INTRA-OCULAR IMPLANT SOCIETY
mended using Type C lenses with extreme caution. Dr Jaffe closed the symposium and asked Dr Clayman to announce the planned study of anterior chamber lenses approved by the Scientific Advisory Board.
393
A short business meeting followed with the new President, Dr Drews, presiding and explaining the upcoming FDA study. The Binkhorst Medal Lecture reception, in honor of Dr Jaffe, followed.
Submitted for publication Dec 8, 1977. Presented at the American Intra-Ocula r Implant Society Meeting, Dallas, Oct 2, 1977.
ported an overall cell reduction of 30% to 35% with all lens implantations, compared to 5% to 15% with routine cataract extraction. His studies have shown a six-fold increase of cell loss with implants over glaucoma procedures caused by the amount of implant endothelial touch at the time of insertion. He strongly urged the insertion of lenses in a closed-eye system with an air-filled formed chamber. Dr Alan Sugar reported a study by Dr Manus Kraff indicating that cell loss increases with the difficulty of the operation. Dr Edward Fetherolf, the 1977 Implant Society Fellow, concluded the report with his work in the development of an animal model, the adult cat, - for endothelial studies. Initial work shows a 7 % loss with simple cataract incision, 10% with incision and air injection, 8% loss with a Choyce lens implant, and a 40% loss after dislocation of an iris clip lens. His studies will continue.
Dr Cornelius Binkhorst emphasized the value of studying the endothelium and cited his paper in the 1972 TRANSACTIONS regarding graphs of cell vitality in relation to cell counts. He also emphasized that corneal dystrophy is the major long-term cause for angle-fixation failure. He cited a 38% increase in cell loss with intracapsular implant vs extracapsular implants and a 50% difference observed in both eyes of the same patient. He warned that long-term safety has not been proved with angle-fixated lenses
390
VO LUM E 85 APRIL 1978
INTRA-OCULAR IMPLANT SOCIETY
and lenses used with phacoemulsification. Dr John Sheets offered a somber note of warning against the impulse to reinvent lens designs, modify previously abandoned and present designs, and use newer, untried materials and techniques without protocols to prove their safety. Dr Kenneth Hoffer reported the results of the use of 70,000 lenses by 734 surgeons, stating the fact that 73% started implants in 1975 and 1976. The Medallion, iris clip, and iridocapsular lenses accounted for 50% of those used, and 61% of those were of European manufacture. He noted 4% secondary implants by one third of the surgeons. The overall visual result, 20/ 40 or better, was 83.8% with a 0.8% removal rate. Dr Richard Keates reported his examination of 12 Surgidev Choyce Mark VIII lenses removed from eyes with the syndrome of uveitis, glaucoma, and hyphema. Sharp and rough edges were found, with poor edge finish causing shearing of the iris stroma. Dr Robert Drews demonstrated the warping of footplates and electron microscopy of saw-like edge finishes on the Surgidev Mark VIII and also showed where the burr edges had embedded in the iris. He also documented degradation of 9-0 nylon, Supramid, and platinum-iridium loops in inflamed eyes with electron microscopy (EM) photographs. The morning session was interrupted by Dr Jaffe to make a surprise presentation of appreciation to Dr Hoffer for his work in the Society and in warning surgeons about defective or contaminated lenses. The meeting continued with
391
an excellent presentation of pathologic evaluation of eyes containing intraocular lenses by Dr John Wright of the Armed Forces Institute of Pathology. The salient aspects were the complete lack of foreign body reaction to polymethylmethacrylate (PMMA), and the EM studies of a lens in an eye for 19 years which showed no change in the PMMA. Atrophy and necrosis of pupillary borders was noted as well as iris pigment dispersal and high attenuation of endothelial cells. David Link, the Director of the FDA Bureau of Medical Devices, presented the history, purpose, and future of FDA involvement in intraocular lenses. He stated that their effectiveness was not in question. Daniel Seigel of the National Eye Institute presented the plans for large randomized controlled studies. The morning session ended with the presentation of the third Binkhorst Medal Lecture by Dr Norman S. Jaffe. It was the highlight of the meeting. For the first time an age-matched retrospective study of 500 patients with and 500 patients without lenses was presented in great detail. The overall results were the same in both groups. The salient features are so important, that the paper should be read in its entirety by all ophthalmologists. Dr Jaffe also presented his tenyear experience with lens implants, compared the Copeland and iris clip lenses, and demonstrated a five-fold increase in cystoid macular edema with intracapsular implants vs extracapsular after one year. Dr Binkhorst presented the Binkhorst Medal to Dr Jaffe with these
392
KENNETH J. HOFFER
words, "It is said that the light of the world comes from two sources, the sun and the student's lamp. The sun is certainly abundant in Miami, and the lamp of Norman Jaffe has contributed much to the science of intraocular lenses." Dr Jaffe accepted the medal and stated that this was his greatest professional honor in his 31 years as a physician. The afternoon session was devoted entirely to a symposium on the recent problems with Choyce lenses. Dr Jaffe moderated the panel based on his lack of bias and experience with this lens. Dr Robert Azar outlined the possible causes of the uveitis-glaucomahyphema syndrome as: the origin of the PMMA (Perspex CQ vs Rohm & Haas), the method of molding, quality control, surgical judgment, errors in surgical technique, and patient predisposition. He reported removing 6 of 27 Surgidev lenses and none of the 800 Rayner lenses. Dr Thomas Ellingson, who initially described this syndrome with Choyce lenses, reported removing 5 of 11 Surgidev and one McGhan. He recommended the use of polarized light to inspect the lens for internal stress. Dr Joseph Giovinco reported no cases of this syndrome in the 168 Rayner lenses he had implanted since 1970. Dr John Corboy demonstrated the physical difference between injectionmolded Rohm & Haas and handlathed Perspex CQ lenses, in that the former shrivel and warp with high temperatures, while the latter are more resistant. Dr Henry Hirschman reported four cases of the syndrome with 16 Surgidev lenses and stressed that patients experience pain on touching the
OPHTH AAOO
eye with the anterior chamber lenses. Dr John Sheets reported a lower overall success rate with anterior chamber lenses of all manufacturers as compared with his use of other lens styles. Dr Richard Kratz stressed the shaving effect of the lens on the iris in 2 out of 17 Surgidev lenses he removed. Drs Norman Stahl and Stephen Obstbaum reported on the gonioscopic aspects of anterior chamber lenses. Dr Obstbaum stressed that torque forces occurring in entering the proximal feet can dislocate previously accurate distal feet. Dr Jerald Tennant mentioned the importance of quality control in these lenses and pointed out that all previous triangular designs caused a high incidence of corneal dystrophy, noting the Kelman lens. Dr Richard Keates pointed out that of the lenses he reported on earlier, 14 were Surgidev and one was McGhan. Dr William McReynolds introduced a new instrument for direct internal measurement of anterior chamber length. He also reported that 3% of the lenses he checked for dioptric power showed a two to nine diopter variance from that labeled. Dr Arthur Hurt reported 86 primary cases with Rayner lenses over 18 months with no occurrence of the syndrome. The symposium was concluded by Mr D. Peter Choyce who categorized anterior chamber lenses according to manufacturer. Type A were Rayner Perspex CQ hand-lathed, polished, and sterilized by caustic soda (on which his 14 years experience are based). Type B lenses were the same but gas sterilized, while Type C were Rohm & Haas injection molded, gas sterilized lenses. He reported the syndrome with one Surgidev and one McGhan lens and recom-
VOLUME 85 APRIL 1978
INTRA-OCULAR IMPLANT SOCIETY
mended using Type C lenses with extreme caution. Dr Jaffe closed the symposium and asked Dr Clayman to announce the planned study of anterior chamber lenses approved by the Scientific Advisory Board.
393
A short business meeting followed with the new President, Dr Drews, presiding and explaining the upcoming FDA study. The Binkhorst Medal Lecture reception, in honor of Dr Jaffe, followed.