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Completed

NCT Number: NCT01809977

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

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Feyz university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collagen cross-linking procedure (total removal)

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.

collagen cross-linking procedure (partial removal)

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.

Primary outcomes

  1. Best corrected visual acuity

    Time frame: at six months after surgery

    determining corrected visual acuity in partial removal versus total removal of the corneal epithelium

Secondary outcomes

  1. Corneal optical density

    Time frame: at six months after surgery

    Corneal optical density was assessed by Scheimpflug densitometry

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Surgical Methods for Keratoconus

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2013
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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