Treatment of Keratoconus Using Collagen Cross-Linking

Keratoconus Clinical Trial

Official title:

Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00841386
• Other study ID #: 101365
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 10, 2009
• Last updated: February 10, 2009
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2009
• Source: University at Buffalo
• Contact: James J. Reidy, M.D.
• Phone: 716-881-7920
• Email: jreidymd[@]mac.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in more advanced cases, scarring of the cornea that may lead to the need for corneal transplantation. Cross-linking has been shown increase the rigidity of the cornea. The patients would be treated once and then followed over 24 months. .

Description:

The goal is for two groups of approximately 66 patients to be included in the study. One eye from the first group will undergo treatment, while the second group of age matched individuals will serve as a control. It will be a prospective, randomized, blinded study. Each patient will be randomized at the beginning of enrollment in the study and will receive a randomization number. The following parameters will be followed: 1. Best corrected spectacle acuity (BCSA) 2. The steepest keratometry measurement (KMax) as measured by computerized corneal topography 3. Apical corneal thickness 4. Corneal mechanical resistance. These measurements will be repeated at 1 month, 3 months, 6 months, 12, 18, and 24 months following treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

Inclusion Criteria:

• no prior history of ocular surgery

• treatment eye must have a maximum corneal power of between 47 D and 60 diopters

• corneal thickness must be greater than 400 µ

• absence of corneal scarring

• patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features:

• high myopia

• corneal ectasia as viewed by slit-lamp exam or measured by pachometry

• Vogt's striae

• topographic findings of superior flattening and inferior steepening of the cornea

• presence of Fleischer ring

Exclusion Criteria:

• history of prior ocular surgery (history of contact lens use is not an exclusion criterion)

• average corneal power > 60 D

• presence of corneal scarring

• corneal thickness 400 µ or less

• history of herpes simplex virus keratitis

• history of uveitis

• pre-existing glaucoma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Drug:
• Riboflavin-5-phosphate
Riboflavin 0.1% (10 mg riboflavin-5-phosphate in 10 ml dextran T-500 20% solution, supplied in a sterile, single dose container) will be applied to the cornea every 2-3 minutes for 15 minutes prior to starting UV irradiation. The UV irradiation will be given in six 5 minute intervals. Additional riboflavin will be administered following each 5 minute UV treatment.
• Sham cross-linking
Topical anesthesia (lidocaine jelly 2%) will be used. Differing from the treatment group, no epithelium will be debrided, but instead, this step will be skipped and 2% methylcellulose solution with 1% sodium fluorescein will be applied to the cornea every 5 minutes for 15 minutes, and then every 5 minutes during the sham UV treatment. The patient will be placed under the UV device, and the aiming beam applied.

Locations

Country	Name	City	State
United States	Fichte,Endl, & Elmer EyeCare	Amherst	New York
United States	The Ira G. Ross Eye Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (9)

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 — View Citation

Kohlhaas M, Spoerl E, Schilde T, Unger G, Wittig C, Pillunat LE. Biomechanical evidence of the distribution of cross-links in corneas treated with riboflavin and ultraviolet A light. J Cataract Refract Surg. 2006 Feb;32(2):279-83. — View Citation

Mazzotta C, Balestrazzi A, Traversi C, Baiocchi S, Caporossi T, Tommasi C, Caporossi A. Treatment of progressive keratoconus by riboflavin-UVA-induced cross-linking of corneal collagen: ultrastructural analysis by Heidelberg Retinal Tomograph II in vivo c — 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

Mencucci R, Mazzotta C, Rossi F, Ponchietti C, Pini R, Baiocchi S, Caporossi A, Menchini U. Riboflavin and ultraviolet A collagen crosslinking: in vivo thermographic analysis of the corneal surface. J Cataract Refract Surg. 2007 Jun;33(6):1005-8. — View Citation

Natarajan R, Padmanabhan P, Guruswami S. Hydration behavior of porcine cornea crosslinked with riboflavin and ultraviolet A. J Cataract Refract Surg. 2007 Sep;33(9):1503. — View Citation

Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. Review. — View Citation

Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. — View Citation

Wollensak G. Crosslinking treatment of progressive keratoconus: new hope. Curr Opin Ophthalmol. 2006 Aug;17(4):356-60. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity		24 months	Yes
Primary	Spherical equivalent power of the cornea (Best spectacle refraction)		24 months	No
Primary	KMax: the maximum corneal curvature		24 months	Yes
Primary	Average corneal power of the cornea in the central 4 mm.		24 months	No
Secondary	Corneal resistance factor.		24 months	No
Secondary	Maximal posterior surface elevation of the cornea.		24 months	No
Secondary	Apical corneal thickness.		24 months	Yes
Secondary	Endothelial count.		24 months	Yes

External Links

•   National Keratoconus Foundation