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Treatment of Keratoconus Using Collagen Cross-Linking

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Riboflavin-5-phosphate
Sham cross-linking
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Cornea, Keratoconus, Ectasia, Riboflavin, Collagen cross-linking

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fichte,Endl, & Elmer EyeCareRecruiting
  • The Ira G. Ross Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cross-linking treatment

Sham treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Best corrected visual acuity
Spherical equivalent power of the cornea (Best spectacle refraction)
KMax: the maximum corneal curvature
Average corneal power of the cornea in the central 4 mm.

Secondary Outcome Measures

Corneal resistance factor.
Maximal posterior surface elevation of the cornea.
Apical corneal thickness.
Endothelial count.

Full Information

First Posted
February 10, 2009
Last Updated
February 10, 2009
Sponsor
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT00841386
Brief Title
Treatment of Keratoconus Using Collagen Cross-Linking
Official Title
Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University at Buffalo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. .
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Cornea, Keratoconus, Ectasia, Riboflavin, Collagen cross-linking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cross-linking treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham treatment group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Riboflavin-5-phosphate
Other Intervention Name(s)
Ricrolin (SOOFT Italia Inc.)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sham cross-linking
Other Intervention Name(s)
Goniosol
Intervention Description
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 Information:
Title
Best corrected visual acuity
Time Frame
24 months
Title
Spherical equivalent power of the cornea (Best spectacle refraction)
Time Frame
24 months
Title
KMax: the maximum corneal curvature
Time Frame
24 months
Title
Average corneal power of the cornea in the central 4 mm.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Corneal resistance factor.
Time Frame
24 months
Title
Maximal posterior surface elevation of the cornea.
Time Frame
24 months
Title
Apical corneal thickness.
Time Frame
24 months
Title
Endothelial count.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James J. Reidy, M.D.
Phone
716-881-7920
Email
jreidymd@mac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne Stutz
Phone
716-881-7920
Email
jstutz@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Reidy, M.D.
Organizational Affiliation
SUNY at Buffalo School of Medicine & Biomedical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fichte,Endl, & Elmer EyeCare
City
Amherst
State/Province
New York
ZIP/Postal Code
14228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Grant, C.O.M.T.
Phone
716-564-2020
Email
linda.grant@fichte.com
First Name & Middle Initial & Last Name & Degree
Michael Endl, M.D.
Phone
716-564-2020
Email
mpderme@aol.com
First Name & Middle Initial & Last Name & Degree
Michael Endl, M.D.
First Name & Middle Initial & Last Name & Degree
Thomas R Elmer, M.D.
Facility Name
The Ira G. Ross Eye Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James J Reidy, M.D.
Phone
716-881-7920
Email
jreidymd@mac.com
First Name & Middle Initial & Last Name & Degree
James J Reidy, M.D.
First Name & Middle Initial & Last Name & Degree
Sandra L Everett, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
17720054
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. doi: 10.1016/j.jcrs.2007.04.047. No abstract available.
Results Reference
result
PubMed Identifier
17457184
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 confocal microscopy in humans. Cornea. 2007 May;26(4):390-7. doi: 10.1097/ICO.0b013e318030df5a.
Results Reference
result
PubMed Identifier
17457183
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. doi: 10.1097/ICO.0b013e3180334f78.
Results Reference
result
PubMed Identifier
16952090
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. doi: 10.1177/112067210601600405.
Results Reference
result
PubMed Identifier
16900027
Citation
Wollensak G. Crosslinking treatment of progressive keratoconus: new hope. Curr Opin Ophthalmol. 2006 Aug;17(4):356-60. doi: 10.1097/01.icu.0000233954.86723.25.
Results Reference
result
PubMed Identifier
16765803
Citation
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. doi: 10.1016/j.jcrs.2006.01.091.
Results Reference
result
PubMed Identifier
16565005
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. doi: 10.1016/j.jcrs.2005.12.092.
Results Reference
result
PubMed Identifier
12719068
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. doi: 10.1016/s0002-9394(02)02220-1.
Results Reference
result
PubMed Identifier
17531694
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. doi: 10.1016/j.jcrs.2007.03.021.
Results Reference
result
Links:
URL
http://www.nkcf.org
Description
National Keratoconus Foundation

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Treatment of Keratoconus Using Collagen Cross-Linking

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