Refractive ErrorPhase 2NCT00918697
Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
A Phase 2 study testing Mechanical debridement and Alcohol-assisted debridement in people with Refractive Error and Myopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Refractive Error, Myopia
- What is being tested?
- Mechanical debridement and Alcohol-assisted debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIran
- Study dates
- Jul 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- spherical equivalent ≤ -4.0 D
- cylinder ≤ 1.50 D
Who cannot join
- history of ocular trauma or surgery
- any corneal and ocular pathologies
- central corneal thickness < 500 µm
- scotopic pupil diameter > 6.0 mm
- any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
- the presence of systemic disorders such as collagen vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial
In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.
- Conditions
- Refractive Error, Myopia
- Being tested
- Mechanical debridement, Alcohol-assisted debridement
- Keywords
- photorefractive keratectomy, PRK, alcohol-assisted debridement, mechanical debridement, confocal scan, confocal microscopy
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridementProcedure or surgery
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.
Alcohol-assisted debridementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical debridment | Active comparator | In this arm, corneal epithelium was removed during PRK using conventional mechanical method. Receives: Procedure: Mechanical debridement |
| Alcohol-asstisted debridement | Experimental | In this arm, corneal epithelium was removed using ethanol 20% during PRK. Receives: Procedure: Alcohol-assisted debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal cellular elements.
Confocal microscopic findings of corneal cellular elements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJul 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918697
- Sponsor's protocol ID
- 8713
- Status last verified
- Apr 2010
- First submitted
- 10 Jun 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial
- ClinicalTrials.gov ID
- NCT00918697
- Acronym / sponsor ID
- 8713
- Conditions
- Refractive Error, Myopia
- Keywords
- photorefractive keratectomy, PRK, alcohol-assisted debridement, mechanical debridement, confocal scan, confocal microscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2009
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical debridment | Active comparator | Procedure: Mechanical debridementIn this arm, corneal epithelium was removed during PRK using conventional mechanical method. |
| Alcohol-asstisted debridement | Experimental | Procedure: Alcohol-assisted debridementIn this arm, corneal epithelium was removed using ethanol 20% during PRK. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- spherical equivalent ≤ -4.0 D
- cylinder ≤ 1.50 D
Key exclusion criteria (6 listed)
- history of ocular trauma or surgery
- any corneal and ocular pathologies
- central corneal thickness < 500 µm
- scotopic pupil diameter > 6.0 mm
- any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical debridementFor 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. | Procedure or surgery | Mechanical debridment |
| Alcohol-assisted debridementFor 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. | Procedure or surgery | Alcohol-asstisted debridement |
Primary outcome
Corneal cellular elements.
Confocal microscopic findings of corneal cellular elements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mechanical debridement and Alcohol-assisted debridement in people with Refractive Error and Myopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal cellular elements.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010; AzTrials last refreshed its copy on 7 Nov 2026.