Ophtec iris reconstruction lens United States clinical trial phase I.
ABSTRACT To determine the safety and efficacy of the Ophtec model 311 iris reconstruction lens for treatment of visual disturbances, such as glare or photophobia, related to partial or total absence of the human iris.
Phase I multicenter, nonrandomized, investigational device study.
Ten iris reconstruction lenses were placed in 10 subjects at 6 sites.
Iris reconstruction lenses were placed in 9 patients who had lost all or part of their iris from trauma and in 1 patient who lacked iris pigmentation due to congenital albinism. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1; week 1; and months 1, 3, 6, and 12.
Efficacy measures were uncorrected visual acuity (UCVA), glare, starbursts, and photophobia. Safety measures were best-corrected visual acuity (VA), surgical complications, and adverse events.
Uncorrected VA improved in all eyes after implantation of the iris reconstruction lens. Best-corrected VA did not change significantly (P = 0.24). Postoperative photophobia was reduced in all 9 eyes that experienced moderate to severe preoperative photophobia. Likewise, postoperative glare was reduced in all 6 eyes with moderate to severe preoperative glare. There were no surgical complications. Adverse events included 2 cases of iritis and 1 case of macular edema.
Preliminary results suggest that the Ophtec model 311 iris reconstruction lens can improve UCVA and reduce glare and photophobia in patients with partial or total absence of the iris or iris pigmentation.
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ABSTRACT: A 17-year-old male patient was referred for poorly controlled glaucoma on maximal medication, congenital aniridia, cataract, nystagmus, and hypoplasia of the macula. A bilateral filtering procedure was performed to control the glaucoma. Three months later, a slow motion phacoemulsification and implantation of a brown diaphragm intraocular lens (IOL) was attempted. Despite the presence of nystagmus and hypoplasia of the macula, the visual acuity improved from 20/300 to 20/100 in the right eye and from 20/400 to 20/150 in the left eye. Both aniridia IOLs were well centered, the anterior segment was quiet with normal intraocular pressure without medication, and all of the patient's glare symptoms disappeared. A single-piece iris diaphragm and optical lens offer a safe alternative for patients who previously had no viable options for iris reconstruction. The most serious postoperative problem, glaucoma, should be addressed before the cataract and lens implantation is performed to avoid a possible acceleration of the glaucoma progression by the large aniridia IOL.Ophthalmic surgery and lasers 33(6):514-7.
- Journal of Cataract [?] Refractive Surgery 08/2002; 28(7):1088-91. · 2.53 Impact Factor
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ABSTRACT: A 25-year-old man had a penetrating injury to the left eye. Ocular examination revealed a full-thickness corneal laceration, total aniridia, anterior capsule rupture, and microscopic hyphema. Ten days after the immediate primary-repair surgery, aspiration of the lens secondary to traumatic cataract was performed. Four months later, a black diaphragm intraocular lens was implanted. Postoperatively, the best corrected visual acuity was 20/20 in both eyes. Multifocal spectacles were prescribed to provide the near and far vision required for the patient's job. Normal intraocular pressure and acceptable photophobia were noted during the 18-month follow-up.Journal of Cataract [?] Refractive Surgery 01/2004; 29(12):2455-7. · 2.53 Impact Factor