NCT00841386

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. .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 11, 2009

Status Verified

January 1, 2009

Enrollment Period

3.2 years

First QC Date

February 10, 2009

Last Update Submit

February 10, 2009

Conditions

Keratoconus

Keywords

CorneaKeratoconusEctasiaRiboflavinCollagen cross-linking

Outcome Measures

Primary Outcomes (4)

  • Best corrected visual acuity

    24 months

  • Spherical equivalent power of the cornea (Best spectacle refraction)

    24 months

  • KMax: the maximum corneal curvature

    24 months

  • Average corneal power of the cornea in the central 4 mm.

    24 months

Secondary Outcomes (4)

  • Corneal resistance factor.

    24 months

  • Maximal posterior surface elevation of the cornea.

    24 months

  • Apical corneal thickness.

    24 months

  • Endothelial count.

    24 months

Study Arms (2)

Cross-linking treatment

EXPERIMENTAL

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.

Drug: Riboflavin-5-phosphate

Sham treatment group

SHAM COMPARATOR

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.

Drug: Sham cross-linking

Interventions

Riboflavin-5-phosphateDRUG

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.

Also known as: Ricrolin (SOOFT Italia Inc.)
Cross-linking treatment
Sham cross-linkingDRUG

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.

Also known as: Goniosol
Sham treatment group

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fichte,Endl, & Elmer EyeCare

Amherst, New York, 14228, United States

RECRUITING

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 17720054RESULT

  • 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.

    PMID: 17457184RESULT

  • 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.

    PMID: 17457183RESULT

  • 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.

    PMID: 16952090RESULT

  • 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.

    PMID: 16900027RESULT

  • 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.

    PMID: 16765803RESULT

  • 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.

    PMID: 16565005RESULT

  • 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.

    PMID: 12719068RESULT

  • 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.

    PMID: 17531694RESULT

Related Links

MeSH Terms

Conditions

KeratoconusCorneal DiseasesDilatation, Pathologic

Interventions

Flavin MononucleotideLubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RiboflavinFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesRibonucleotidesNucleotidesNucleic Acids, Nucleotides, and NucleosidesPigments, BiologicalBiological FactorsOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • James J Reidy, M.D.

    SUNY at Buffalo School of Medicine & Biomedical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James J. Reidy, M.D.

CONTACT

716-881-7920jreidymd@mac.com

Jeanne Stutz

CONTACT

716-881-7920jstutz@buffalo.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 11, 2009

Record last verified: 2009-01

Locations

US(2)