Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

Keratoconus Clinical Trial

Official title:

Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143389
• Other study ID #: 2010-0243
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: August 30, 2017

Study information

• Verified date: May 2018
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: August 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Keratoconus
• Post-Refractive Ectasia

Intervention

Drug:
• Riboflavin
Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.

Device:
• UVX light
UVX 365 nm wavelength light source is applied with continued application of riboflavin.

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Price Vision Group

Country where clinical trial is conducted

United States, 

References & Publications (4)

Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. — View Citation

Mazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. — View Citation

Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039. — View Citation

Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximum Keratometry From Baseline to 6 Months After Treatment	Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.	6 months
Secondary	Pachymetry	Minimum corneal thickness measured by corneal tomography	6 months
Secondary	Corrected Distance Visual Acuity (CDVA)	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.	6 months
Secondary	Uncorrected Distance Visual Acuity (UDVA)	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.	6 months

External Links

•   Price Vision Group Website