PURPOSE To evaluate the safety and efficacy of a custom-manufactured artificial iris device (CUST... more PURPOSE To evaluate the safety and efficacy of a custom-manufactured artificial iris device (CUSTOMFLEX® ARTIFICIALIRIS; HumanOptics AG, Erlangen Germany) for the treatment of congenital and acquired iris defects. DESIGN Multicenter, prospective, unmasked, non-randomized, interventional clinical trial PARTICIPANTS: Patients with photophobia and/or glare sensitivity secondary to partial or complete congenital or acquired iris defects METHODS: Eyes were implanted from November 26, 2013 to December 1, 2017 with a custom, foldable artificial iris by one of four different surgical techniques, depending on anterior segment pathology. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. At each examination, slit lamp biomicroscopy findings, intraocular pressure, implant position, subjective visual complaints, and any complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were also measured at 3, 6, and/or 12 months as additional safety evaluations. The National Eye Institute (NEI) Visual Function Questionnaire-25 (VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale (GAIS) was used to assess cosmetic results. MAIN OUTCOME MEASURES Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, GAIS rating, artificial iris-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months postoperatively. RESULTS At the 12-month postoperative examination there was a 59.7% reduction in marked to severe daytime light sensitivity (p<0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (p<0.0001), a 53.1% reduction in marked to severe daytime glare (p<0.0001), and a 48.5% reduction in severe nighttime glare (p<0.0001) sensitivity. There was a 15.4-point improvement (p<0.0001) in the NEI VFQ-25 total score, and 93.8% of patients reported an improvement in cosmesis as measured by the GAIS 12 months postoperatively. There was no loss of CDVA greater than 2 lines related to the device. Median ECD loss was 5.3% at 6 months postoperatively and 7.2% at 12 months postoperatively. CONCLUSIONS The HumanOptics artificial iris surpassed all key safety endpoints for adverse events related to the device, IOL, or implant surgery and met all key efficacy endpoints including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.
Stenotic lesions of varying magnitudes were induced in the common carotid arteries of rabbits. Re... more Stenotic lesions of varying magnitudes were induced in the common carotid arteries of rabbits. Resulting alterations in carotid blood flow were correlated with changes in the ocular, external maxillary, long posterior ciliary, and central ear artery pressure pulses. A reduction of the common carotid artery lumen of approximately 45% was necessary before blood flow was reduced. Progressively greater degrees of stenosis had a much greater effect on blood flow than on blood pressure. Changes in the systolic and diastolic portions of the flow pattern were reflected in the ocular and blood vessel pulses by a decrease in amplitude, reduction in slope of the anacrotic and catacrotic limbs, rounding of the crest with a slight delay, or double peaking of the crest and a dicrotic notch that occurred higher than normal on the catacrotic limb or was absent.
In experiments on living cats ocular volume changes were measured at various intraocular pressure... more In experiments on living cats ocular volume changes were measured at various intraocular pressures after acute common carotid occlusion. A semilogarithmic relationship was found between ocular blood volume changes and the level of intraocular pressure after carotid occlusion. The slope of this relationship, termed the "coefficient of vascular rigidity," was found to correspond to similar measurements made in enucleated cat eyes by direct ophthalmic artery perfusion. The results of this study permitted a quantitative approach to the measurement of vascular rigidity in human eyes by using the carotid compression-tonography test with the 5.5 and 10.0 gm plunger weights. The normal coefficient of vascular rigidity is approximately 0.0238.
Multifocal intraocular lenses (IOLs) have been designed to provide improved near visual acuity wi... more Multifocal intraocular lenses (IOLs) have been designed to provide improved near visual acuity without spectacles compared with monofocal IOLs. Early studies have reported variables amounts of decreased visual acuity and contrast sensitivity with multifocal IOLs, and some patients have experienced halos and glare. The authors performed a prospective, double-masked, multicenter evaluation of 62 patients randomized between a new zonal-progressive optic multifocal IOL and a monofocal IOL. Mean postoperative spherical equivalent, astigmatism, and uncorrected and best-corrected distance visual acuity were similar between the two groups. Patients with a multifocal IOL achieved significantly better uncorrected near visual acuity than patients with monofocal IOLs (J3+ versus J7; P less than 0.0001). With distance correction only, mean near visual acuity was J2 versus J5- (P = 0.0001). Best-corrected near visual acuity was J1 for both groups, with 1.36 diopters (D) for the multifocal group versus 2.37 D for the monofocal group (P less than 0.0001). Regan contrast sensitivity was lower for the multifocal patients at all contrast levels, and achieved statistical significance at very low contrast (11% contrast; P = 0.0024). Fifty-two percent of patients with a multifocal IOL reported that they did not need spectacles at all or used them only for their fellow eye, compared with 25% of the patients with monofocal IOLs. Both monofocal and multifocal implant patients were very satisfied with the results of their cataract extraction and IOL implant surgery. A small loss of contrast sensitivity with the multifocal IOL was demonstrated, consistent with theoretical predictions. The functional significance of the loss of contrast sensitivity appears to be small and counterbalanced by the advantage of improved uncorrected near visual acuity.
Awareness of the limitations of Snellen vision testing and the favorable risk-to-benefit ratio fo... more Awareness of the limitations of Snellen vision testing and the favorable risk-to-benefit ratio for cataract surgery have changed the indications for cataract rehabilitation. Interest in functional vision analysis generated the present study, which was designed to identify cataract-specific disabling glare and its reversal with best-case cataract surgical techniques. Thirty eyes with symptomatic cataracts and no other ocular diseases were evaluated by Miller-Nadler glare testing prior to and six weeks after surgery. All surgical cases were uncomplicated and were free of macular disease. They had well-centered posterior chamber intraocular lenses, clean posterior capsules, and were returned to 20/20 Snellen acuity. Careful patient selection assured that presurgical glare disability was due to cataract formation. Presurgical Miller-Nadler scores were markedly elevated and correlated well with symptomatic glare, whereas postoperative scores were indistinguishable from normals, suggesting that cataract-induced symptomatic glare is discernible, remediable, and warrants surgical intervention, but requires best-case surgery to assure glare reversal.
To assess the safety and efficacy of Morcher 67B black iris diaphragm intraocular lens (IOL) impl... more To assess the safety and efficacy of Morcher 67B black iris diaphragm intraocular lens (IOL) implantation for managing large iris defects and aphakia. Stein Eye Institute, UCLA, Los Angeles, California, USA. Prospective case series. The demographic, preoperative, and postoperative data on patients implanted with a black iris diaphragm IOL and followed to 1Â year were reviewed. Safety measures included loss of corrected distance visual acuity (CDVA), perioperative complications, adverse events, and secondary surgical interventions. Efficacy measures included CDVA with glare, daytime and nighttime glare symptom scores, and subjective cosmesis scores. Thirty-one eyes of 31 patients were implanted. There was a 7-line improvement in median Snellen CDVA (PÂ <Â .001). Four eyes worsened more than 1 line. There was 1 minor intraoperative complication. Twenty-one eyes experienced postoperative complications, most of which were related to preexisting ocular comorbidities. Three adverse events...
With tolerated spectacles she manifests a constant exotropia of 35 prism diopters without diplopi... more With tolerated spectacles she manifests a constant exotropia of 35 prism diopters without diplopia; however, with full optical correction by contact lenses she maintains fusion. Physical findings include a small, probably insignificant (approximately 0.5 mm) posterior subcapsular cataract and modest central retinal myopic changes for the right eye; the retinal periphery shows several areas of lattice degeneration but no holes are found. The left eye is unremarkable. Both eyes present clear, healthy corneas with excellent endothelia and deep anterior chambers with normal angle structures.
C Postoperative atonic pupil following seemingly routine cataract extraction represents an enigma... more C Postoperative atonic pupil following seemingly routine cataract extraction represents an enigmatic and troublesome, albeit rare, complication. It is characterized by an enlarged, unresponsive pupil that does not constrict with the application of pilocarpine but does dilate after installation of mydriatics, suggesting specific damage to the pupillary sphincter. What is the incidence of this condition in your experience, what is your concept of its etiology, how do you prevent its occurrence, and how do you manage patients' symptoms, which are usually related to disabling glare?
g An active 71-year-old male had uncomplicated penetrating keratoplasty in his right eye 18 month... more g An active 71-year-old male had uncomplicated penetrating keratoplasty in his right eye 18 months ago for decompensated Fuchs' dystrophy. hree years earlier, in the same eye and under the care of another surgeon, he had extracapsular cataract extraction (ECCE) with implantation of a posterior chamber intraocular lens (IOL); the posterior capsule was left intact. His records indicate that postoperatively he developed iridocapsular adhesions with distortion of the superior pupil. His postsurgical course was also eventful for the development of visually significant cystoid macular edema (CME) at four months; it responded fully to topical therapy and the patient did well until his recent corneal decompensation. The fellow eye also shows advancing Fuchs' dystrophy but has not had corneal or cataract surgery. After the recent and uncomplicated keratoplasty, CME returned but was ameliorated with local therapy. At the time of keratoplasty, the iridocapsular adhesions were left undisturbed as was peripheral posterior capsular "pearling." A 7. 7 mm donor button (endothelial punch method) was placed in a 7.5 mm recipient bed (vacuum trephinated). Water-tight closure was accomplished with 12 interrupted 10-0 nylon sutures and one 12-bite running 10-0 nylon suture. Between three and six months after surgery, the individual sutures were removed sequentially for astigmatism reduction, as dictated by photokeratoscopy. The running suture remains in place. The graft has remained clear and acuity is correctable to 20/30with a -6.25 -2.50 x 90 spectacle lens. Unfortunately, spectacle correction has led to aniseikonic asthenopia since the fellow left eye requires a +2.25 -0.7 5 x 78 spectacle lens for best vision. As a result, the right eye was fitted with a toric soft contact lens, which corrected vision well and was easily tolerated but induced significant corneal neovascularization, necessitating its discontinuance. Subsequently, a rigid gaspermeable lens was fitted, has provided excellent vision, and has yielded binocular visual comfort. Nevertheless, the patient has had great tactile difficulty in managing the lens and loses a lens weekly. He has become highly reliant on his right eye since vision in the left eye has progressively worsened (20/80 best corrected) because of the Fuchs' dystrophy. An additional and developing problem is progressive posterior capsular clouding in the right eye with Elschnig pearls now reaching the visual axis. The posterior segment is normal for both eyes at this time. Given that for the right eye, the patient cannot be expected to have long-term aniseikonic success with a contact lens and posterior capsular clouding will soon limit vision and that corneal decompensation is imminent in the left eye, how would you provide this patient with good binocular vision?
PURPOSE To evaluate the safety and efficacy of a custom-manufactured artificial iris device (CUST... more PURPOSE To evaluate the safety and efficacy of a custom-manufactured artificial iris device (CUSTOMFLEX® ARTIFICIALIRIS; HumanOptics AG, Erlangen Germany) for the treatment of congenital and acquired iris defects. DESIGN Multicenter, prospective, unmasked, non-randomized, interventional clinical trial PARTICIPANTS: Patients with photophobia and/or glare sensitivity secondary to partial or complete congenital or acquired iris defects METHODS: Eyes were implanted from November 26, 2013 to December 1, 2017 with a custom, foldable artificial iris by one of four different surgical techniques, depending on anterior segment pathology. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. At each examination, slit lamp biomicroscopy findings, intraocular pressure, implant position, subjective visual complaints, and any complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were also measured at 3, 6, and/or 12 months as additional safety evaluations. The National Eye Institute (NEI) Visual Function Questionnaire-25 (VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale (GAIS) was used to assess cosmetic results. MAIN OUTCOME MEASURES Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, GAIS rating, artificial iris-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months postoperatively. RESULTS At the 12-month postoperative examination there was a 59.7% reduction in marked to severe daytime light sensitivity (p<0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (p<0.0001), a 53.1% reduction in marked to severe daytime glare (p<0.0001), and a 48.5% reduction in severe nighttime glare (p<0.0001) sensitivity. There was a 15.4-point improvement (p<0.0001) in the NEI VFQ-25 total score, and 93.8% of patients reported an improvement in cosmesis as measured by the GAIS 12 months postoperatively. There was no loss of CDVA greater than 2 lines related to the device. Median ECD loss was 5.3% at 6 months postoperatively and 7.2% at 12 months postoperatively. CONCLUSIONS The HumanOptics artificial iris surpassed all key safety endpoints for adverse events related to the device, IOL, or implant surgery and met all key efficacy endpoints including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.
Stenotic lesions of varying magnitudes were induced in the common carotid arteries of rabbits. Re... more Stenotic lesions of varying magnitudes were induced in the common carotid arteries of rabbits. Resulting alterations in carotid blood flow were correlated with changes in the ocular, external maxillary, long posterior ciliary, and central ear artery pressure pulses. A reduction of the common carotid artery lumen of approximately 45% was necessary before blood flow was reduced. Progressively greater degrees of stenosis had a much greater effect on blood flow than on blood pressure. Changes in the systolic and diastolic portions of the flow pattern were reflected in the ocular and blood vessel pulses by a decrease in amplitude, reduction in slope of the anacrotic and catacrotic limbs, rounding of the crest with a slight delay, or double peaking of the crest and a dicrotic notch that occurred higher than normal on the catacrotic limb or was absent.
In experiments on living cats ocular volume changes were measured at various intraocular pressure... more In experiments on living cats ocular volume changes were measured at various intraocular pressures after acute common carotid occlusion. A semilogarithmic relationship was found between ocular blood volume changes and the level of intraocular pressure after carotid occlusion. The slope of this relationship, termed the "coefficient of vascular rigidity," was found to correspond to similar measurements made in enucleated cat eyes by direct ophthalmic artery perfusion. The results of this study permitted a quantitative approach to the measurement of vascular rigidity in human eyes by using the carotid compression-tonography test with the 5.5 and 10.0 gm plunger weights. The normal coefficient of vascular rigidity is approximately 0.0238.
Multifocal intraocular lenses (IOLs) have been designed to provide improved near visual acuity wi... more Multifocal intraocular lenses (IOLs) have been designed to provide improved near visual acuity without spectacles compared with monofocal IOLs. Early studies have reported variables amounts of decreased visual acuity and contrast sensitivity with multifocal IOLs, and some patients have experienced halos and glare. The authors performed a prospective, double-masked, multicenter evaluation of 62 patients randomized between a new zonal-progressive optic multifocal IOL and a monofocal IOL. Mean postoperative spherical equivalent, astigmatism, and uncorrected and best-corrected distance visual acuity were similar between the two groups. Patients with a multifocal IOL achieved significantly better uncorrected near visual acuity than patients with monofocal IOLs (J3+ versus J7; P less than 0.0001). With distance correction only, mean near visual acuity was J2 versus J5- (P = 0.0001). Best-corrected near visual acuity was J1 for both groups, with 1.36 diopters (D) for the multifocal group versus 2.37 D for the monofocal group (P less than 0.0001). Regan contrast sensitivity was lower for the multifocal patients at all contrast levels, and achieved statistical significance at very low contrast (11% contrast; P = 0.0024). Fifty-two percent of patients with a multifocal IOL reported that they did not need spectacles at all or used them only for their fellow eye, compared with 25% of the patients with monofocal IOLs. Both monofocal and multifocal implant patients were very satisfied with the results of their cataract extraction and IOL implant surgery. A small loss of contrast sensitivity with the multifocal IOL was demonstrated, consistent with theoretical predictions. The functional significance of the loss of contrast sensitivity appears to be small and counterbalanced by the advantage of improved uncorrected near visual acuity.
Awareness of the limitations of Snellen vision testing and the favorable risk-to-benefit ratio fo... more Awareness of the limitations of Snellen vision testing and the favorable risk-to-benefit ratio for cataract surgery have changed the indications for cataract rehabilitation. Interest in functional vision analysis generated the present study, which was designed to identify cataract-specific disabling glare and its reversal with best-case cataract surgical techniques. Thirty eyes with symptomatic cataracts and no other ocular diseases were evaluated by Miller-Nadler glare testing prior to and six weeks after surgery. All surgical cases were uncomplicated and were free of macular disease. They had well-centered posterior chamber intraocular lenses, clean posterior capsules, and were returned to 20/20 Snellen acuity. Careful patient selection assured that presurgical glare disability was due to cataract formation. Presurgical Miller-Nadler scores were markedly elevated and correlated well with symptomatic glare, whereas postoperative scores were indistinguishable from normals, suggesting that cataract-induced symptomatic glare is discernible, remediable, and warrants surgical intervention, but requires best-case surgery to assure glare reversal.
To assess the safety and efficacy of Morcher 67B black iris diaphragm intraocular lens (IOL) impl... more To assess the safety and efficacy of Morcher 67B black iris diaphragm intraocular lens (IOL) implantation for managing large iris defects and aphakia. Stein Eye Institute, UCLA, Los Angeles, California, USA. Prospective case series. The demographic, preoperative, and postoperative data on patients implanted with a black iris diaphragm IOL and followed to 1Â year were reviewed. Safety measures included loss of corrected distance visual acuity (CDVA), perioperative complications, adverse events, and secondary surgical interventions. Efficacy measures included CDVA with glare, daytime and nighttime glare symptom scores, and subjective cosmesis scores. Thirty-one eyes of 31 patients were implanted. There was a 7-line improvement in median Snellen CDVA (PÂ <Â .001). Four eyes worsened more than 1 line. There was 1 minor intraoperative complication. Twenty-one eyes experienced postoperative complications, most of which were related to preexisting ocular comorbidities. Three adverse events...
With tolerated spectacles she manifests a constant exotropia of 35 prism diopters without diplopi... more With tolerated spectacles she manifests a constant exotropia of 35 prism diopters without diplopia; however, with full optical correction by contact lenses she maintains fusion. Physical findings include a small, probably insignificant (approximately 0.5 mm) posterior subcapsular cataract and modest central retinal myopic changes for the right eye; the retinal periphery shows several areas of lattice degeneration but no holes are found. The left eye is unremarkable. Both eyes present clear, healthy corneas with excellent endothelia and deep anterior chambers with normal angle structures.
C Postoperative atonic pupil following seemingly routine cataract extraction represents an enigma... more C Postoperative atonic pupil following seemingly routine cataract extraction represents an enigmatic and troublesome, albeit rare, complication. It is characterized by an enlarged, unresponsive pupil that does not constrict with the application of pilocarpine but does dilate after installation of mydriatics, suggesting specific damage to the pupillary sphincter. What is the incidence of this condition in your experience, what is your concept of its etiology, how do you prevent its occurrence, and how do you manage patients' symptoms, which are usually related to disabling glare?
g An active 71-year-old male had uncomplicated penetrating keratoplasty in his right eye 18 month... more g An active 71-year-old male had uncomplicated penetrating keratoplasty in his right eye 18 months ago for decompensated Fuchs' dystrophy. hree years earlier, in the same eye and under the care of another surgeon, he had extracapsular cataract extraction (ECCE) with implantation of a posterior chamber intraocular lens (IOL); the posterior capsule was left intact. His records indicate that postoperatively he developed iridocapsular adhesions with distortion of the superior pupil. His postsurgical course was also eventful for the development of visually significant cystoid macular edema (CME) at four months; it responded fully to topical therapy and the patient did well until his recent corneal decompensation. The fellow eye also shows advancing Fuchs' dystrophy but has not had corneal or cataract surgery. After the recent and uncomplicated keratoplasty, CME returned but was ameliorated with local therapy. At the time of keratoplasty, the iridocapsular adhesions were left undisturbed as was peripheral posterior capsular "pearling." A 7. 7 mm donor button (endothelial punch method) was placed in a 7.5 mm recipient bed (vacuum trephinated). Water-tight closure was accomplished with 12 interrupted 10-0 nylon sutures and one 12-bite running 10-0 nylon suture. Between three and six months after surgery, the individual sutures were removed sequentially for astigmatism reduction, as dictated by photokeratoscopy. The running suture remains in place. The graft has remained clear and acuity is correctable to 20/30with a -6.25 -2.50 x 90 spectacle lens. Unfortunately, spectacle correction has led to aniseikonic asthenopia since the fellow left eye requires a +2.25 -0.7 5 x 78 spectacle lens for best vision. As a result, the right eye was fitted with a toric soft contact lens, which corrected vision well and was easily tolerated but induced significant corneal neovascularization, necessitating its discontinuance. Subsequently, a rigid gaspermeable lens was fitted, has provided excellent vision, and has yielded binocular visual comfort. Nevertheless, the patient has had great tactile difficulty in managing the lens and loses a lens weekly. He has become highly reliant on his right eye since vision in the left eye has progressively worsened (20/80 best corrected) because of the Fuchs' dystrophy. An additional and developing problem is progressive posterior capsular clouding in the right eye with Elschnig pearls now reaching the visual axis. The posterior segment is normal for both eyes at this time. Given that for the right eye, the patient cannot be expected to have long-term aniseikonic success with a contact lens and posterior capsular clouding will soon limit vision and that corneal decompensation is imminent in the left eye, how would you provide this patient with good binocular vision?
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