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

Study of Surgical Methods for Keratoconus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01809977

Enrollment

Registered

2013-03-13

Start date

2012-07-31

Completion date

2012-12-31

Last updated

2013-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, remove, cornea, visual acuity

Brief summary

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

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.

Interventions

PROCEDUREcollagen 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.

PROCEDUREcollagen 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Corneal optical density	at six months after surgery	Corneal optical density was assessed by Scheimpflug densitometry

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026