MyopiaH-TransPKRNCT05072977
Photorefractive Keratectomy (PRK) : Comparison of Corneal Haze Between Two Modes of De-epithelialisation (Laser Versus Manual Alcohol)
A study testing TransPRK and Alcohol PRK in people with Myopia and Astigmatism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- TransPRK and Alcohol PRK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2022to 10 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned Photorefractive Keratectomy in both eyes
- Simple myopia or myopic astigmatism, refractive spherical equivalent between -0.50 and -9.0 diopters in both eyes with regular corneal topography
Who cannot join
- Only one eye operated on
- At least one contraindication to refractive surgery, namely : keratoconus, minimum corneal thickness < 400 µm, severe dry syndrome, progressive corneal infection
- Personal history of corneal surgery
- Personal history of ocular pathology other than simple myopia or myopic astigmatism
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy
surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile.
This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.
- Conditions
- Myopia, Astigmatism
- Being tested
- TransPRK, Alcohol PRK
- Keywords
- Myopia, Astigmatism, Corneal haze, Trans Photorefractive Keratectomy, Alcohol Photorefractive Keratectomy
- Medical subject headings
- Myopia, Astigmatism, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransPRKProcedure or surgery
A Merocel sponge is soaked in a saline solution to expand before being gently applied to the corneal surface in three gestures similar to painting. This standardised procedure avoids inhomogeneous wetting of the cornea, which would result in uneven ablation. The laser ablation is then performed.
Alcohol PRKProcedure or surgery
A ring is placed in the centre of the cornea and filled with 20% alcohol. After 20 seconds of exposure, the alcohol is absorbed with a small sponge and the corneal epithelium is debrided with a polyvinyl alcohol expanding sponge (Merocel, Medtronic). The entire cornea is rinsed with balanced salt solution and the epithelium is peeled away from the corneal stroma. The corneal bed is then dried with a small sponge and laser ablation is performed.
| Study group | Role | What they receive |
|---|---|---|
| TransPRK | Experimental | Not described Receives: Procedure: TransPRK |
| Alcohol PRK | Active comparator | Not described Receives: Procedure: Alcohol PRK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal haze assessed with the the software analysing the corneal OCT images
Corneal haze assessed by the intensity of the luminosity of the whole cornea (expressed as a percentage) evaluated by the software analysing the corneal OCT images.
Measured: 1 month after refractive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start9 Feb 2022
- Primary completion5 Jun 2023
- Study completion10 Jul 2024
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alain SAAD, MD, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072977
- Sponsor's protocol ID
- ASD_2021_8
- Acronym
- H-TransPKR
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT05072977
- Acronym / sponsor ID
- H-TransPKR / ASD_2021_8
- Conditions
- Myopia, Astigmatism
- Keywords
- Myopia, Astigmatism, Corneal haze, Trans Photorefractive Keratectomy, Alcohol Photorefractive Keratectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- 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.
surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile.
This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TransPRK | Experimental | Procedure: TransPRK |
| Alcohol PRK | Active comparator | Procedure: Alcohol PRK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned Photorefractive Keratectomy in both eyes
- Simple myopia or myopic astigmatism, refractive spherical equivalent between -0.50 and -9.0 diopters in both eyes with regular corneal topography
Key exclusion criteria (5 listed)
- Only one eye operated on
- At least one contraindication to refractive surgery, namely : keratoconus, minimum corneal thickness < 400 µm, severe dry syndrome, progressive corneal infection
- Personal history of corneal surgery
- Personal history of ocular pathology other than simple myopia or myopic astigmatism
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| TransPRKA Merocel sponge is soaked in a saline solution to expand before being gently applied to the corneal surface in three gestures similar to painting. This standardised procedure avoids inhomogeneous wetting of the cornea, which would result in uneven ablation. The laser ablation is then performed. | Procedure or surgery | TransPRK |
| Alcohol PRKA ring is placed in the centre of the cornea and filled with 20% alcohol. After 20 seconds of exposure, the alcohol is absorbed with a small sponge and the corneal epithelium is debrided with a polyvinyl alcohol expanding sponge (Merocel, Medtronic). The entire cornea is rinsed with balanced salt solution and the epithelium is peeled away from the corneal stroma. The corneal bed is then dried with a small sponge and laser ablation is performed. | Procedure or surgery | Alcohol PRK |
Primary outcome
Corneal haze assessed with the the software analysing the corneal OCT images
Time frame: 1 month after refractive surgery
Corneal haze assessed by the intensity of the luminosity of the whole cornea (expressed as a percentage) evaluated by the software analysing the corneal OCT images.
Results and safety
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Alain SAAD, MD principal investigator
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransPRK and Alcohol PRK in people with Myopia and Astigmatism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 8 Dec 2025. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
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 haze assessed with the the software analysing the corneal OCT images (time frame: 1 month after refractive surgery). 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 8 Dec 2025.