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

NCT ID: NCT01809977

Last Updated: 2013-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

collagen cross-linking procedure (total removal)

Intervention Type PROCEDURE

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.

Group Type OTHER

collagen cross-linking procedure (partial removal)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Shemshaki

MD, Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Behrooz Rahimi, MD

Role: PRINCIPAL_INVESTIGATOR

MD, Departement of ophtalmology, Isfahan University of Medical Sciences, Isfahan, Iran

Locations

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Feyz university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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Razmjoo H, Rahimi B, Kharraji M, Koosha N, Peyman A. Corneal haze and visual outcome after collagen crosslinking for keratoconus: A comparison between total epithelium off and partial epithelial removal methods. Adv Biomed Res. 2014 Nov 29;3:221. doi: 10.4103/2277-9175.145677. eCollection 2014.

Reference Type DERIVED
PMID: 25538907 (View on PubMed)

Other Identifiers

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ASD-1213-39

Identifier Type: -

Identifier Source: org_study_id

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