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

Keratoconus Clinical Trial

Official title:

Study of Surgical Methods for Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809977
• Other study ID #: ASD-1213-39
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2013
• Last updated: March 11, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Feyz university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	determining corrected visual acuity in partial removal versus total removal of the corneal epithelium	at six months after surgery	Yes
Secondary	Corneal optical density	Corneal optical density was assessed by Scheimpflug densitometry	at six months after surgery	Yes

External Links

•   Isfahan university of medical sciences