The Effects of Corneal Collagen Cross-linking

• Sponsor: Rush Eye Associates (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01708538
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 120
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.

Condition or Disease	Intervention/Treatment	Phase
Corneal Ectasia Disorders Including Keratoconus	Drug: CXL	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.
• Study Start Date: Oct 1, 2012
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Epithelium on Epi not removed during CXL treatment	Drug: CXL; corneal crosslinking
Active Comparator: Epithelium off Epi removed before CXL treatment	Drug: CXL; corneal crosslinking

Outcome Measures

Primary Outcome Measures

1. Visual acuity [1 year]

   Best corrected Snellen acuity

2. Keratometry measurements [1 year]

   Average curvature of the cornea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 10-70, willing to participate, diagnosis of corneal ectasia disorder

Exclusion Criteria:

• Unwilling or unable to participate in trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush Eye Associates	Amarillo	Texas	United States	79106

Sponsors and Collaborators

• Rush Eye Associates

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rush Eye Associates
• ClinicalTrials.gov Identifier: NCT01708538
• Other Study ID Numbers: Rush CXL
• First Posted: Oct 17, 2012
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Rush Eye Associates: keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia
• Additional relevant MeSH terms: Keratoconus; Dilatation, Pathologic

Study Results

No Results Posted as of Mar 10, 2021