Ophtec iris reconstruction lens United States clinical trial phase I.
OBJECTIVE
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.


METHODS
Phase I multicenter, nonrandomized, investigational device study.


METHODS
Ten iris reconstruction lenses were placed in 10 subjects at 6 sites.


METHODS
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.


METHODS
Efficacy measures were uncorrected visual acuity (UCVA), glare, starbursts, and photophobia. Safety measures were best-corrected visual acuity (VA), surgical complications, and adverse events.


RESULTS
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.


CONCLUSIONS
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.
Cornea Research Foundation of America, Indianapolis, Indiana, USA.
Marianne O
MO
Price
Francis W
FW
Price
David F
DF
Chang
Kathy
K
Kelley
Michael D
MD
Olson
Kevin M
KM
Miller
D000328:Adult; D000368:Aged; D005131:Eye Injuries / Q000601:surgery*; D005260:Female; D019466:Glare; D006801:Humans; D007498:Iris / Q000293:injuries*; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D020795:Photophobia / Q000517:prevention & control*; D011446:Prospective Studies; D011474:Prosthesis Design; D012449:Safety; D035703:Therapies, Investigational; D016896:Treatment Outcome; D014481:United States; D014792:Visual Acuity