Moderate HyperopiaNCT05261685
Single-step Transepithelial PRK for Hyperopia
A study testing Single-step transepithelial PRK in people with Moderate Hyperopia, run by Assiut University at 1 site in Egypt.
Trial summary
Hyperopia is one of the commonest refractive errors encountered in ophthalmology practice. Laser in situ keratomileusis (LASIK) has been widely used to correct hyperopia especially with the advent of femtosecond laser technology allowing larger flap creation suitable for peripheral hyperopic ablations with resultant… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate Hyperopia
- What is being tested?
- Single-step transepithelial PRK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 15 Dec 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
- Patients with moderate hyperopia with a hyperopic cycloplegic spherical equivalent between +2 and + 4.5 diopters D.
- A steep keratometry (Ks) ≤ 46 D.
- Minimum pachymetry of 500 μm with a calculated residual stromal bed exceeding 350 μm after epithelial and stromal ablation.
Who cannot join
- Patients not candidate for corneal refractive surgery,
- Steep cornea (Ks > 46 D) with an expected postoperative keratometry > 48 D,
- Large angle kappa as estimated by Chord mu > 0.25 mm,
- Hyperopic amblyopia whether unilateral or bilateral with CDVA less than 0.2 . logMAR acuity,
- Recent contact lens wear, dry eye disease and autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Twelve-Month Outcome of Single-step Transepithelial Photorefractive Keratectomy for Moderate Hyperopia and Hyperopic Astigmatism
Hyperopia is one of the commonest refractive errors encountered in ophthalmology practice.
Laser in situ keratomileusis (LASIK) has been widely used to correct hyperopia especially with the advent of femtosecond laser technology allowing larger flap creation suitable for peripheral hyperopic ablations with resultant predictable, effective, and safe refractive outcomes. However, the encountered LASIK flap complications encouraged many surgeons to assess efficiency and safety of surface ablation techniques such as photorefractive keratectomy (PRK) to correct hyperopia.
Read the detailed description
Although the initial refractive results of conventional manual or alcohol assisted PRK for hyperopia were encouraging, the frequently encountered post-PRK complications including undercorrection, overcorrection and regression of the hyperopic error had downgraded the conventional PRK as a preferred procedure for hyperopic correction.
Transepithelial PRK provides an alternative technique to uniformly remove the epithelium using the excimer laser to minimize the potential complications caused by mechanical or alcohol assisted epithelial removal in conventional PRK. Advances in transepithelial PRK technology have allowed refractive surgeons to remove the epithelium followed by stromal laser ablation in a single step instead of performing the procedure in 2 separate steps known as phototherapeutic keratectomy-photorefractive keratectomy (PTK-PRK).
Most of the previous studies paid particular attention to investigate the accuracy and safety of single-step transepithelial PRK in correcting myopia and myopic astigmatism. The aim of the current study is to evaluate the visual and refractive outcomes of the single-step transepithelial PRK procedure in correcting moderate hyperopia and hyperopic astigmatism.
- Conditions
- Moderate Hyperopia
- Being tested
- Single-step transepithelial PRK
- Keywords
- Single-step PRK, StreamLight PRK, Hyperopia, Photorefractive keratectomy
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-step transepithelial PRKProcedure or surgery
Single-step transepithelial Photorefractive keratectomy (PRK) is a corneal refractive surgical procedure utilized to correct myopia, hyperopia and astigmatism where excimer laser is used in a single step to remove the corneal epithelium followed by stromal laser ablation to correct the patient's refractive error.
| Study group | Role | What they receive |
|---|---|---|
| Hyperopic patients planned to undergo single-step transepithelial PRK | Experimental | Patients with moderate hyperopia or hyperopic astigmatism were planned to undergo transepithelial PRK using the new single-step StreamLight PRK Technology. Receives: Procedure: Single-step transepithelial PRK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Uncorrected and corrected distance visual acuity (UDVA,CDVA) measurement using logMAR distant charts.
Measured: 12 months
Cycloplegic refraction
Cycloplegic sphere, cylinder and refractive spherical equivalent (SEQ) were measured with auto-keratorefractometer (KR-8900:Topcon, Korea republic)
Measured: 12 months
Secondary outcomes (2)
Keratometry and corneal asphericity
Postoperative keratorefractive changes in mean keratometry (Km) and Q value were recorded using pentacam (Oculus GmbH, Germany)
Measured: 12 months
Post-PRK haze
Post-PRK haze was evaluated using slit lamp based on Fantes et al. scale:
Grade 0: No haze, completely clear cornea
Grade 0.5: Trace haze seen with careful oblique illumination
Grade 1: Haze not interfering with the visibility of fine details of the iris
Grade 2: Mild obstruction of iris details
Grade 3: Moderate obstruction of the iris and lens
Grade 4: Complete opacification of the stroma in the area of the scar, anterior chamber is totally obscured.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2019
- Primary completion15 Dec 2021
- Study completion15 Dec 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 Moderate HyperopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdel-Radi, Assiut University
- Investigators
- Mahmoud Abdel-Radi, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261685
- Sponsor's protocol ID
- STEPRKH
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adib-Moghaddam S, Arba-Mosquera S, Walter-Fincke R, Soleyman-Jahi S, Adili-Aghdam F. Transepithelial Photorefractive Keratectomy for Hyperopia: A 12-Month Bicentral Study. J Refract Surg. 2016 Mar;32(3):172-80. doi: 10.3928/1081597X-20160121-01.
PubMed 27027624Abdel-Radi M, Rateb M, Saleh MGA, Aly MOM. Twelve-month outcomes of single-step transepithelial photorefractive keratectomy for moderate hyperopia and hyperopic astigmatism. Eye Vis (Lond). 2023 Mar 1;10(1):7. doi: 10.1186/s40662-023-00327-4.
PubMed 36855211
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-Month Outcome of Single-step Transepithelial Photorefractive Keratectomy for Moderate Hyperopia and Hyperopic Astigmatism
- ClinicalTrials.gov ID
- NCT05261685
- Acronym / sponsor ID
- STEPRKH
- Conditions
- Moderate Hyperopia
- Keywords
- Single-step PRK, StreamLight PRK, Hyperopia, Photorefractive keratectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 2 Mar 2022 (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.
Hyperopia is one of the commonest refractive errors encountered in ophthalmology practice.
Laser in situ keratomileusis (LASIK) has been widely used to correct hyperopia especially with the advent of femtosecond laser technology allowing larger flap creation suitable for peripheral hyperopic ablations with resultant predictable, effective, and safe refractive outcomes. However, the encountered LASIK flap complications encouraged many surgeons to assess efficiency and safety of surface ablation techniques such as photorefractive keratectomy (PRK) to correct hyperopia.
Detailed description
Although the initial refractive results of conventional manual or alcohol assisted PRK for hyperopia were encouraging, the frequently encountered post-PRK complications including undercorrection, overcorrection and regression of the hyperopic error had downgraded the conventional PRK as a preferred procedure for hyperopic correction.
Transepithelial PRK provides an alternative technique to uniformly remove the epithelium using the excimer laser to minimize the potential complications caused by mechanical or alcohol assisted epithelial removal in conventional PRK. Advances in transepithelial PRK technology have allowed refractive surgeons to remove the epithelium followed by stromal laser ablation in a single step instead of performing the procedure in 2 separate steps known as phototherapeutic keratectomy-photorefractive keratectomy (PTK-PRK).
Most of the previous studies paid particular attention to investigate the accuracy and safety of single-step transepithelial PRK in correcting myopia and myopic astigmatism. The aim of the current study is to evaluate the visual and refractive outcomes of the single-step transepithelial PRK procedure in correcting moderate hyperopia and hyperopic astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperopic patients planned to undergo single-step transepithelial PRK | Experimental | Procedure: Single-step transepithelial PRKPatients with moderate hyperopia or hyperopic astigmatism were planned to undergo transepithelial PRK using the new single-step StreamLight PRK Technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with moderate hyperopia with a hyperopic cycloplegic spherical equivalent between +2 and + 4.5 diopters D.
- A steep keratometry (Ks) ≤ 46 D.
- Minimum pachymetry of 500 μm with a calculated residual stromal bed exceeding 350 μm after epithelial and stromal ablation.
Key exclusion criteria (5 listed)
- Patients not candidate for corneal refractive surgery,
- Steep cornea (Ks > 46 D) with an expected postoperative keratometry > 48 D,
- Large angle kappa as estimated by Chord mu > 0.25 mm,
- Hyperopic amblyopia whether unilateral or bilateral with CDVA less than 0.2 . logMAR acuity,
- Recent contact lens wear, dry eye disease and autoimmune 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 |
|---|---|---|
| Single-step transepithelial PRKSingle-step transepithelial Photorefractive keratectomy (PRK) is a corneal refractive surgical procedure utilized to correct myopia, hyperopia and astigmatism where excimer laser is used in a single step to remove the corneal epithelium followed by stromal laser ablation to correct the patient's refractive error. | Procedure or surgery | Hyperopic patients planned to undergo single-step transepithelial PRK |
Primary outcome
Visual acuity
Time frame: 12 months
Uncorrected and corrected distance visual acuity (UDVA,CDVA) measurement using logMAR distant charts.
Cycloplegic refraction
Time frame: 12 months
Cycloplegic sphere, cylinder and refractive spherical equivalent (SEQ) were measured with auto-keratorefractometer (KR-8900:Topcon, Korea republic)
2 secondary outcomes
Keratometry and corneal asphericity
Time frame: 12 months
Post-PRK haze
Time frame: 12 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 12 Jul 2022.
- Background: PubMed 27027624Adib-Moghaddam S, Arba-Mosquera S, Walter-Fincke R, Soleyman-Jahi S, Adili-Aghdam F. Transepithelial Photorefractive Keratectomy for Hyperopia: A 12-Month Bicentral Study. J Refract Surg. 2016 Mar;32(3):172-80. doi: 10.3928/1081597X-20160121-01.
- Derived from this study: PubMed 36855211Abdel-Radi M, Rateb M, Saleh MGA, Aly MOM. Twelve-month outcomes of single-step transepithelial photorefractive keratectomy for moderate hyperopia and hyperopic astigmatism. Eye Vis (Lond). 2023 Mar 1;10(1):7. doi: 10.1186/s40662-023-00327-4.
- 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.
Mahmoud Abdel-Radi principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-step transepithelial PRK in people with Moderate Hyperopia, 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 3 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: finished, as of the sponsor's last update on 12 Jul 2022. 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?
Visual acuity (time frame: 12 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 NCT05261685, 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 12 Jul 2022.