Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

Phase 2

Completed

• Conditions: Keratoconus; Post-Refractive Ectasia
• Interventions: Drug: Riboflavin; Device: UVX light

• Registration Number: NCT01143389
• Lead Sponsor: Price Vision Group

Brief Summary

The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.

Detailed Description

The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2017-05-30
• Study Completion: 2017-08-30
• Results First Submitted: 2018-04-03
• Results First Submitted QC: 2018-04-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Results First Posted: 2018-05-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

1. 10 years of age or older

2. Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:

   1. An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
   2. An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
   3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
   4. Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.

3. Subjects with keratoconus diagnosis only:

   a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring

4. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:

   Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks

5. Signed written informed consent

Exclusion Criteria

• 1. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.

  2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:

  a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.

  5. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.

  6. Pregnancy (including plan to become pregnant) or lactation during the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Riboflavin 0.1% eyedrops every 5 minutes	UVX light	The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin 0.1% eyedrops every 2 minutes	UVX light	The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin 0.1% eyedrops every 5 minutes	Riboflavin	The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin 0.1% eyedrops every 2 minutes	Riboflavin	The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).

Primary Outcome Measures

Name	Time	Method
Change in Maximum Keratometry From Baseline to 6 Months After Treatment	6 months	Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.

Secondary Outcome Measures

Name	Time	Method
Corrected Distance Visual Acuity (CDVA)	6 months	Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
Uncorrected Distance Visual Acuity (UDVA)	6 months	Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
Pachymetry	6 months	Minimum corneal thickness measured by corneal tomography

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States