Recruiting
Phase 2
Phase 3

Collagen Cross-Linking

Sponsor:

University at Buffalo

Code:

NCT00841386

Conditions

Keratoconus

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Accepted

Interventions

Riboflavin-5-phosphate

Sham cross-linking

Study Details

Brief 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. .

Conditions

Keratoconus

Study ID

NCT00841386

Start date

Sep, 2008

Status verified date

Jan, 2009

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cross-linking treatment

Topical anesthesia (lidocaine jelly 2%) will be used. The central 9 mm of corneal epithelium will be removed cautiously with an Amoils brush. Riboflavin 0.1% solution will be applied (10 mg riboflavin-5-phosphate in 10 ml dextran T-500 20% solution, supplied in a sterile, single dose container) to the cornea every 2-3 minutes for 15 minutes and then every 5 minutes thereafter. The UV source will be from the CBM VEGA X-linker (CSO, Florence, Italy). A wavelength of 370 nm will be used to direct 5.4 J/cm2 to the area of cornea debrided for 30 minutes. The distance from the UV source to the cornea will be 1.5 to 5.4 cm.

sham comparator: Sham treatment group

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 a 2% methylcellulose solution combined with 1% fluorescein dye will be applied to the cornea every 5 minutes for 30 minutes. The patient will be placed under the UV device, but instead of the UV light, the LED aiming beam will be applied for 30 minutes.

Interventions

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.

Primary outcome measure

  • Best corrected visual acuity [ Time Frame: 24 months ]
  • Spherical equivalent power of the cornea (Best spectacle refraction) [ Time Frame: 24 months ]
  • KMax: the maximum corneal curvature [ Time Frame: 24 months ]
  • Average corneal power of the cornea in the central 4 mm. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

James J. Reidy, M.D.

716-881-7920jreidymd@mac.com

Jeanne Stutz

716-881-7920jstutz@buffalo.edu

Locations

Fichte,Endl, & Elmer EyeCare

Recruiting

Amherst, New York, United States, 14228

Contacts

Linda Grant, C.O.M.T.

716-564-2020linda.grant@fichte.com

Michael Endl, M.D.

716-564-2020mpderme@aol.com

Principal Investigator:

Michael Endl, M.D.

The Ira G. Ross Eye Institute

Recruiting

Buffalo, New York, United States, 14209

Contacts

James J Reidy, M.D.

716-881-7920jreidymd@mac.com

Principal Investigator:

James J Reidy, M.D.

More Information

Sponsor

University at Buffalo

Last update posted

Feb 11, 2009

Last verified

Jan, 2009

Keywords

  • Cornea
  • Keratoconus
  • Ectasia
  • Riboflavin
  • Collagen cross-linking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University at Buffalo on 2009-02-11.