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

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ClinicalTrials.gov Identifier: NCT01809977
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences

Brief Summary:
The purpose of this study is to determine which surgical method makes less corneal haze

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Keratoconus
Study Start Date : July 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: at six months after surgery ]
    determining corrected visual acuity in partial removal versus total removal of the corneal epithelium


Secondary Outcome Measures :
  1. Corneal optical density [ Time Frame: at six months after surgery ]
    Corneal optical density was assessed by Scheimpflug densitometry



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809977


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases