Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
|ClinicalTrials.gov Identifier: NCT00918697|
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : October 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Refractive Error Myopia||Procedure: Mechanical debridement Procedure: Alcohol-assisted debridement||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial|
|Study Start Date :||July 2009|
|Study Completion Date :||March 2010|
Active Comparator: Mechanical debridment
In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
Procedure: Mechanical debridement
For mechanical epithelial removal, an 8.0-mm optical zone marker was applied to the cornea, centering over the entrance pupil. A hockey spatula was used to remove the central corneal epithelium.
Experimental: Alcohol-asstisted debridement
In this arm, corneal epithelium was removed using ethanol 20% during PRK.
Procedure: Alcohol-assisted debridement
For alcohol-assisted debridement, 20% ethyl-alcohol solution was instilled into an 8.0-mm well and kept in contact with epithelium for 20 seconds (being careful to avoid spillage over the areas not being treated). It then absorbed using a dry cellulose sponge followed by copious irrigation with BSS. The epithelium of the central cornea was removed using a blunt spatula.
- Corneal cellular elements.Confocal microscopic findings of corneal cellular elements.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918697
|Iran, Islamic Republic of|
|Ophthalmic Research Center|
|Tehran, Iran, Islamic Republic of, 16666|