Corneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)

The Ohio State University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Progressive Keratoconus; Corneal Ectasia

Treatments: Drug: Placebo; Drug: Riboflavin

Study type: Interventional

Funder types: Other

Identifiers

NCT00679666

2008H0050,2008H0049

Details and patient eligibility

About

Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

Full description

After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of keratoconus with documented progression over the previous 12 months.
• Diagnosis of corneal ectasia
• Must be able to complete all study visits.

Exclusion criteria

• Prior corneal surgery in keratoconus group
• Corneal scarring
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Sham treatment

Sham Comparator group

Description:

Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.

Treatment:

Drug: Placebo

Treatment Arm

Active Comparator group

Description:

After randomization, the active arm will have the collagen crosslinking intervention.

Treatment:

Drug: Riboflavin