Trial record 30 of 90 for:    cornea AND cross-linking

Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01809977
First received: March 8, 2013
Last updated: March 11, 2013
Last verified: March 2013
  Purpose
The purpose of this study is to determine which surgical method makes less corneal haze

Condition Intervention Phase
Keratoconus
Procedure: collagen cross-linking procedure (total removal)
Procedure: collagen cross-linking procedure (partial removal)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Keratoconus

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: at six months after surgery ] [ Designated as safety issue: Yes ]
    determining corrected visual acuity in partial removal versus total removal of the corneal epithelium


Secondary Outcome Measures:
  • Corneal optical density [ Time Frame: at six months after surgery ] [ Designated as safety issue: Yes ]
    Corneal optical density was assessed by Scheimpflug densitometry


Enrollment: 22
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
total removal
patients underwent Corneal collagen cross-linking procedure with totally corneal epithelium removing. Total removal was performed by mechanical debridement of the corneal epithelium over the central 9 mm.
Procedure: collagen cross-linking procedure (total removal)
patients underwent Corneal collagen cross-linking procedure with totally corneal epithelium removing. Total removal was performed by mechanical debridement of the corneal epithelium over the central 9 mm.
partial removal
patients underwent Corneal collagen cross-linking procedure with partially corneal epithelium removing. Partial removal was performed by removing a 3-mm width ring and leaving the central 3 mm of the cornea intact.
Procedure: collagen cross-linking procedure (partial removal)
patients underwent Corneal collagen cross-linking procedure with partially corneal epithelium removing. Partial removal was performed by removing a 3-mm width ring and leaving the central 3 mm of the cornea intact.

Detailed Description:
Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea. The investigators evaluate whether partial removal versus total removal of the corneal epithelium can lead to less corneal haze and better visual outcomes.
  Eligibility

Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 16-40 years
  • axial topography consistent with keratoconus
  • minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months

Exclusion Criteria:

  • history of ocular herpes or non-healing corneal ulcers
  • subjects with current ocular infection
  • severe preoperative corneal haze or scar
  • severe ocular surface disease
  • autoimmune diseases
  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809977

Locations
Iran, Islamic Republic of
Feyz university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Behrooz Rahimi, MD MD, Departement of ophtalmology, Isfahan University of Medical Sciences, Isfahan, Iran
  More Information

Additional Information:
Responsible Party: Hamidreza Shemshaki, MD, Research Assistant, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01809977     History of Changes
Other Study ID Numbers: ASD-1213-39 
Study First Received: March 8, 2013
Last Updated: March 11, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Keratoconus
remove
cornea
visual acuity

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2016