Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus

NCT00815256 | Unknown Phase 3 DMC

• 1 other identifier: 1970/07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus.

Conditions

Cornea Degeneration; Progressive Keratoconus

Keywords

Cornea degeneration; keratoconus; collagen cross linking; CXL; Riboflavin

Outcome Measures

Primary Outcomes (1)

• Stop progression of keratoconus in cornea imaging exams

  1, 3, 6 and 12 months

Secondary Outcomes (1)

• Increase in the collagen fibrils density in the confocal microscopy; sensitivity in the esthesiometry; Keratometry (stabilizes or reduces) in the topography; anterior chamber depth on pentacan; etc

  1, 3, 6 and 12 months

Study Arms (1)

Cross linking (CXL)

EXPERIMENTAL

Patients with progressive mild and moderate grades of ketatoconus are randomized and allocated to this group and submitted to the treatment with riboflavin and ultraviolet -A light. They do not match any of the exclusion criterion: pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy.

Procedure: Collagen Cross Linking with Riboflavin and UVA light

Interventions

Collagen Cross Linking with Riboflavin and UVA light PROCEDURE

The patients randomized and allocated to this group are submitted to the treatment with riboflavin and ultraviolet -A light, if they do not match any of the exclusion criterion. The treatment is done as follows:after topical anesthesia, the epithelial tissue was removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution were applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution were continuously applied onto the cornea every 5 min. After the procedure, a therapeutic contact lens and antibiotic eye ointment are applied onto the cornea for a week. We see the patient in the next day.

Cross linking (CXL)

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Keratoconus patients, with progression of the disease, based on an increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on pentacan, in a period of at least six months.

You may not qualify if:

• pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Department of Ophthalmology, Federal University of São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 18471635 RESULT

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Denise D Freitas, Professor

  Ophthalmology Department Chair

  STUDY CHAIR

Central Study Contacts

Patricia Z Serapicos, MD

CONTACT

55(11)82738907; patricia.serapicos@yahoo.com.br

Kátia M Bottós, MD

CONTACT

55(11)81848519; katia.bottos@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Last Updated: December 29, 2008

Record last verified: 2008-11

Locations

BR (1)