Treatment of Keratoconus Using Collagen Cross-Linking

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in more advanced cases, scarring of the cornea that may lead to the need for corneal transplantation. Cross-linking has been shown increase the rigidity of the cornea. The patients would be treated once and then followed over 24 months. .

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University at Buffalo
• Treatments: Flavin Mononucleotide; Lidocaine; Pharmaceutical Solutions; Riboflavin

Criteria

Inclusion Criteria:

• no prior history of ocular surgery

• treatment eye must have a maximum corneal power of between 47 D and 60 diopters

• corneal thickness must be greater than 400 µ

• absence of corneal scarring

• patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features:

• high myopia

• corneal ectasia as viewed by slit-lamp exam or measured by pachometry

• Vogt's striae

• topographic findings of superior flattening and inferior steepening of the cornea

• presence of Fleischer ring

Exclusion Criteria:

• history of prior ocular surgery (history of contact lens use is not an exclusion criterion)

• average corneal power > 60 D

• presence of corneal scarring

• corneal thickness 400 µ or less

• history of herpes simplex virus keratitis

• history of uveitis

• pre-existing glaucoma