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

Study Overview
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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.

Official Title
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Study of Surgical Methods for Keratoconus

Conditions
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Keratoconus

Intervention / Treatment
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* Procedure: collagen cross-linking procedure (total removal)
* Procedure: collagen cross-linking procedure (partial removal)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: total removal<br>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)<br>* 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.<br>|
| Other: partial removal<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | determining corrected visual acuity in partial removal versus total removal of the corneal epithelium | at six months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal optical density | Corneal optical density was assessed by Scheimpflug densitometry | at six months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoconus, remove, cornea, visual acuity