Comparison of Standard vs. Accelerated Corneal Crosslinking

Price Vision Group

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Keratoconus; Ectasia Corneal

Treatments: Combination Product: Riboflavin 0.1%; Combination Product: riboflavin 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922542

2019-003

Details and patient eligibility

About

The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.

Enrollment: 510 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented keratoconus or ectasia after refractive surgery

Exclusion criteria

• Insufficient corneal thickness
• Ocular condition that may predispose the eye to complications
• History of chemical injury or delayed epithelial healing
• Condition that would interfere with or prolong epithelial healing
• Known sensitivity to treatment medications
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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510 participants in 2 patient groups

Accelerated

Active Comparator group

Description:

Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes

Treatment:

Combination Product: riboflavin 0.1%

Standard

Active Comparator group

Description:

Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes

Treatment:

Combination Product: Riboflavin 0.1%