Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Joao Nassaralla, Instituto de Olhos de Goiania

ClinicalTrials.gov Identifier:

NCT01485211

First received: November 23, 2011

Last updated: December 2, 2011

Last verified: November 2011

History of Changes

Purpose

The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Condition	Intervention	Phase
Progressive Keratoconus Thin Corneas	Drug: cross-linking with hypo-osmolar riboflavin	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Hypo-osmolar Riboflavin Solution in Thin Corneas

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders

Drug Information available for: Riboflavin

U.S. FDA Resources

Further study details as provided by Instituto de Olhos de Goiania:

Primary Outcome Measures:

Corneal thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas [ Time Frame: Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months. ] [ Designated as safety issue: Yes ]
To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking treatment with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas with progressive keratoconus.

Enrollment:	18
Study Start Date:	January 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: crosslinking with hypoosmolar riboflavin Riboflavin and UVA-induced corneal cross-linking increases the stability of keratoconic corneas. The current inclusion criteria require a minimum stromal thickness of 400 µm. Hypo-osmolar riboflavin solution increases the stromal thickness before CXL in cases with preoperatively thin corneas.	Drug: cross-linking with hypo-osmolar riboflavin Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months. Other Names: Riboflavin UVA radiation

Arms

Assigned Interventions

Experimental: crosslinking with hypoosmolar riboflavin

Riboflavin and UVA-induced corneal cross-linking increases the stability of keratoconic corneas. The current inclusion criteria require a minimum stromal thickness of 400 µm. Hypo-osmolar riboflavin solution increases the stromal thickness before CXL in cases with preoperatively thin corneas.

Drug: cross-linking with hypo-osmolar riboflavin

Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Other Names:

Riboflavin
UVA radiation

Detailed Description:

To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.

After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Progressive Keratoconus
thin corneas

Exclusion Criteria:

Contact lens use for less than 3 weeks
Non progressive keratoconus
Thinest corneal thickness above 400 micra

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485211

Sponsors and Collaborators

Instituto de Olhos de Goiania

Investigators

Study Chair:

Belquiz A Nassaralla, MD, PhD

Instituto de Olhos de Goiania

More Information

No publications provided

Responsible Party:	Joao Nassaralla, Clinical Professor, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:	NCT01485211 History of Changes
Other Study ID Numbers:	BQ - 5 - 11 -ARVO
Study First Received:	November 23, 2011
Last Updated:	December 2, 2011
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:

progressive keratoconus
thin corneas
cross-linking
hypo-osmolar riboflavin

Additional relevant MeSH terms:

Corneal Diseases
Keratoconus
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013

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