Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
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|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|