Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 DioptersNCT04710082
Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures
A study testing Photorefractive keratectomy (PRK) in people with Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 Diopters, run by Assiut University at 1 site in Egypt.
Trial summary
Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 Diopters
- What is being tested?
- Photorefractive keratectomy (PRK)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 30 Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients not candidates for LVC.
- Hyperopic patients.
- Systemic disease that contraindicates LVC.
- Intra- or post-operative complications.
Trial locations and contacts
1 site in 1 country.
About this study
Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK (StreamLight PRK, Alcon lab, TX, USA).
Read the detailed description
Photorefractive keratectomy (PRK) is nowadays one of the commonest refractive procedures in laser vision correction (LVC). PRK differs from laser in situ keratomileusis (LASIK) in that it's a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal , alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy (PTK). Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK).
Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile.
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted.
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.
- Being tested
- Photorefractive keratectomy (PRK)
- Keywords
- Photorefractive Keratectomy PRK, Phototherapeutic Keratectomy PTK, Trans-epithelial PRK, Laser Vision Correction LVC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photorefractive keratectomy (PRK)Procedure or surgery
Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK | Active comparator | Patients planned to undergo:
1. Epithelial removal using Phototherapeutic Keratectomy PTK as a separate step.
2. Laser Vision Correction using Excimer laser wavefront optimized technology. Receives: Procedure: Photorefractive keratectomy (PRK) |
| Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK. | Active comparator | Patients planned to undergo:
Epithelial removal and Excimer wavefront optimized Laser Vision Correction in a single step using the new StreamLight Technology. Receives: Procedure: Photorefractive keratectomy (PRK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distant visual acuity (UDVA)
Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
Measured: 6 months
Postoperative Refraction (Spherical equivalent)
Measured by Topcon Auto-Keratorefractometer
Measured: 6 months
Secondary outcomes (3)
Epithelial healing duration
Time for the epithelium to heal reported in days after PRK procudre
Measured: 2 weeks
Postoperative pain
Verbal Rating Scale(a series of words commonly used to describe pain (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: disabling pain)
Measured: 1 week
Postoperative Haze
Corneal Haze scoring using slit lamp bio-microscopy according to Fantes scoring system:
0: No haze, completely clear cornea
0.5: Trace haze seen with careful oblique illumination
- Haze not interfering with visibility of fine iris details
- Mild obscuration of iris details
- Moderate obscuration of the iris and lens
- Complete opacification of the stroma in the area of the scar, anterior chamber is totally obscured
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jun 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 DioptersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdel-Radi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710082
- Sponsor's protocol ID
- TEPRK
- Status last verified
- Jul 2021
- First submitted
- 8 Jan 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaluzny BJ, Cieslinska I, Mosquera SA, Verma S. Single-Step Transepithelial PRK vs Alcohol-Assisted PRK in Myopia and Compound Myopic Astigmatism Correction. Medicine (Baltimore). 2016 Feb;95(6):e1993. doi: 10.1097/MD.0000000000001993.
PubMed 26871764Abdel-Radi M, Shehata M, Mostafa MM, Aly MOM. Transepithelial photorefractive keratectomy: a prospective randomized comparative study between the two-step and the single-step techniques. Eye (Lond). 2023 Jun;37(8):1545-1552. doi: 10.1038/s41433-022-02174-4. Epub 2022 Jul 21.
PubMed 35864163
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures
- ClinicalTrials.gov ID
- NCT04710082
- Acronym / sponsor ID
- TEPRK
- Keywords
- Photorefractive Keratectomy PRK, Phototherapeutic Keratectomy PTK, Trans-epithelial PRK, Laser Vision Correction LVC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Jan 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.
Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK (StreamLight PRK, Alcon lab, TX, USA).
Detailed description
Photorefractive keratectomy (PRK) is nowadays one of the commonest refractive procedures in laser vision correction (LVC). PRK differs from laser in situ keratomileusis (LASIK) in that it's a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal , alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy (PTK). Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK).
Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile.
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted.
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK | Active comparator | Procedure: Photorefractive keratectomy (PRK)Patients planned to undergo: 1. Epithelial removal using Phototherapeutic Keratectomy PTK as a separate step. 2. Laser Vision Correction using Excimer laser wavefront optimized technology. |
| Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK. | Active comparator | Procedure: Photorefractive keratectomy (PRK)Patients planned to undergo: Epithelial removal and Excimer wavefront optimized Laser Vision Correction in a single step using the new StreamLight Technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Photorefractive keratectomy (PRK)Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism. | Procedure or surgery | Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK, Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK. |
Primary outcome
Uncorrected distant visual acuity (UDVA)
Time frame: 6 months
Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
Postoperative Refraction (Spherical equivalent)
Time frame: 6 months
Measured by Topcon Auto-Keratorefractometer
3 secondary outcomes
Epithelial healing duration
Time frame: 2 weeks
Postoperative pain
Time frame: 1 week
Postoperative Haze
Time frame: 3 months
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 20 Jul 2021.
- Background: PubMed 26871764Kaluzny BJ, Cieslinska I, Mosquera SA, Verma S. Single-Step Transepithelial PRK vs Alcohol-Assisted PRK in Myopia and Compound Myopic Astigmatism Correction. Medicine (Baltimore). 2016 Feb;95(6):e1993. doi: 10.1097/MD.0000000000001993.
- Derived from this study: PubMed 35864163Abdel-Radi M, Shehata M, Mostafa MM, Aly MOM. Transepithelial photorefractive keratectomy: a prospective randomized comparative study between the two-step and the single-step techniques. Eye (Lond). 2023 Jun;37(8):1545-1552. doi: 10.1038/s41433-022-02174-4. Epub 2022 Jul 21.
- Individual participant dataSharing planned: No
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 study testing Photorefractive keratectomy (PRK) in people with Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 Diopters, run by Assiut University at 1 site in Egypt.
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 0 inclusion and 4 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 20 Jul 2021. 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 Egypt. 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 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?
Uncorrected distant visual acuity (UDVA) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710082, which also lists 2 linked publications.
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 20 Jul 2021.