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

NCT01809977 | Completed Phase 2 DMC

• 1 other identifier: ASD-1213-39
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keratoconus

Keywords

Keratoconus; remove; cornea; visual acuity

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity

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

  at six months after surgery

Secondary Outcomes (1)

• Corneal optical density

  at six months after surgery

Study Arms (2)

total removal

OTHER

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)

partial removal

OTHER

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)

Interventions

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.

total removal

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.

partial removal

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Feyz university hospital

Isfahan, Isfahan, Iran

Location

Related Publications (1)

• 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.

  PMID: 25538907 DERIVED

MeSH Terms

Conditions

Keratoconus; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Behrooz Rahimi, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research Assistant

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 13, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

IR (1)