Back to resultsComparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus
Primary Purpose
Keratoconus
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
collagen cross-linking procedure (total removal)
collagen cross-linking procedure (partial removal)
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, remove, cornea, visual acuity
Eligibility Criteria
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
Sites / Locations
- Feyz university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
total removal
partial removal
Arm 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.
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.
Outcomes
Primary Outcome Measures
Best corrected visual acuity
determining corrected visual acuity in partial removal versus total removal of the corneal epithelium
Secondary Outcome Measures
Corneal optical density
Corneal optical density was assessed by Scheimpflug densitometry
Full Information
NCT ID
NCT01809977
First Posted
March 8, 2013
Last Updated
March 11, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01809977
Brief Title
Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus
Official Title
Study of Surgical Methods for Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, remove, cornea, visual acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
total removal
Arm Type
Other
Arm 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.
Arm Title
partial removal
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
collagen cross-linking procedure (total removal)
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
collagen cross-linking procedure (partial removal)
Intervention 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.
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
determining corrected visual acuity in partial removal versus total removal of the corneal epithelium
Time Frame
at six months after surgery
Secondary Outcome Measure Information:
Title
Corneal optical density
Description
Corneal optical density was assessed by Scheimpflug densitometry
Time Frame
at six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behrooz Rahimi, MD
Organizational Affiliation
MD, Departement of ophtalmology, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feyz university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25538907
Citation
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.
Results Reference
derived
Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical sciences
Learn more about this trial
Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus
We'll reach out to this number within 24 hrs