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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Keratoconus

Treatments: Procedure: collagen cross-linking procedure (partial removal); Procedure: collagen cross-linking procedure (total removal)

Study type: Interventional

Funder types: Other

Identifiers

NCT01809977

ASD-1213-39

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

total removal

Other group

Description:

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.

Treatment:

Procedure: collagen cross-linking procedure (total removal)

partial removal

Other group

Description:

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.

Treatment:

Procedure: collagen cross-linking procedure (partial removal)