Corneal Crosslinking in Keratoconus and Corneal Ectasia

NCT00679666 | Withdrawn Phase 2

• 1 other identifier: 2008H0050,2008H0049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Progressive Keratoconus; Corneal Ectasia

Keywords

keratoconus; ectasia; cross-linking; riboflavin; UVA light; cornea

Outcome Measures

Primary Outcomes (1)

• change in keratometry

  3 months

Secondary Outcomes (1)

• best spectacle-corrected visual acuity

  3 months

Study Arms (2)

Sham treatment

SHAM COMPARATOR

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.

Drug: Placebo

Treatment Arm

ACTIVE COMPARATOR

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

Drug: Riboflavin

Interventions

Riboflavin DRUG

01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes

Also known as: Vitamin B2

Treatment Arm

Placebo DRUG

Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.

Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (2)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

OSU Havener Eye Institute

Dublin, Ohio, 43016, United States

Location

MeSH Terms

Conditions

Keratoconus; Dilatation, Pathologic; Corneal Diseases

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Richard Keates, MD

  The Ohio State Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: May 19, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (2)