MyopiaNCT06393855
Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain
A study testing single-step Trans-PRK, Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye. and Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye. in people with Myopia, run by Dongyang People's Hospital at 1 site in China.
Trial summary
The objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following Trans-PRK in patients characterized by steep corneas and high myopia. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- single-step Trans-PRK, Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye. and Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye.
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2024to 31 Dec 2025
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Spherical equivalent refractive error between -6.00 and -8.00 D in either eye.
- Astigmatism of no more than 2.0 D in either eye.
- Best spectacle-corrected visual acuity (BCVA) according to the logarithm of the Minimum angle of resolution (logMAR) scale of 0 or better in both eyes.
- Willing and able to participate in all required activities of the study.
Who cannot join
- Diabetes mellitus.
- Systemic connective tissue disease.
- Cardiovascular disease, epilepsy.
- Eyelid abnormalities.
- Corneal disease.
- Glaucoma.
- A history of ocular disease.
- Noncompliance with measurement at enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongyang People's Hospital
Dongyang, Zhejiang, 322100
Gengmin Tong, +8613588649648, fkstrer@163.com
About this study
Official title: Base Curves of Bandage Contact Lenses and Their Effects on Post Transepithelial Photorefractive Keratectomy (Trans-PRK) Vision and Pain： A Prospective Randomized Clinical Trial
The objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following Trans-PRK in patients characterized by steep corneas and high myopia.
Read the detailed description
Comparing two kind of bandage lenses in the contralateral eyes of the same individual following Trans-PRK may enable the derivation of reliable conclusions regarding the optimal choice for bandage lenses after Trans-PRK.
- Conditions
- Myopia
- Being tested
- single-step Trans-PRK, Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye., Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye.
- Keywords
- Transepithelial photorefractive keratectomy, High Myopia, bandage contact lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-step Trans-PRKProcedure or surgery
Both eyes were treated consecutively in each patient by single-step Trans-PRK performed by SCHWIND Amaris 500 S excimer laser platform (SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany). Topical Proparacaine Hydrochloride Eye Drops 0.5% (Alcaine, Alcon, Fort Worth, TX, USA) were used to anesthetize the eyes, and use povidone-iodine to disinfect the eyelid skin. After a lid speculum had been inserted, and the other eye was blocked. Epithelial and stromal ablations were performed using a single continuous laser shooting session on an excimer laser platform. After the appeals step, Mitomycin C 0.02 % was applied to the stromal surface for 20 s, then rinse with cold salt water.
Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye.Behavioural
After surgery. A contact lens placed on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye.
Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye.Behavioural
After surgery. A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye.
| Study group | Role | What they receive |
|---|---|---|
| contact lens with 8.4-mm base curve in right eye | Experimental | A contact lens placed on the cornea after the single-step Trans-PRK，with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye Receives: Procedure: single-step Trans-PRK; Behavioral: Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye. |
| contact lens with 8.8-mm base curve in right eye | Experimental | A contact lens placed on the cornea after the single-step Trans-PRK，with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye Receives: Procedure: single-step Trans-PRK; Behavioral: Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative uncorrected visual acuity
All visual acuity measurements were performed using a standard logarithmic eye chart
Measured: 14 days
Secondary outcomes (3)
re-epithelialization after Trans-PRK
A ophthalmologist will examine the corneal epithelium in all eyes. The assessment of corneal epithelial defects involves measuring the horizontal and vertical diameters using a slit lamp beam with a ruler. The extent of corneal epithelial defects is determined by calculating the area of the ellipse (S=πa×b).
Measured: 1 week
postoperative pain score after Trans-PRK
Patients will be asked to complete a pain questionnaire at postoperative 0, 2, 12 hours and 1, 4, 7, 14 days. A visual analog scale (VAS) was employed to assess the severity of pain in each eye. The scores are defined as follows: 0 points: no pain; 1-3 points: mild pain, does not affect work and life; 4-6 points: moderate pain, affects work, does not affect life; 7-10 points: severe pain, affects both work and life
Measured: 2 weeks
spherical equivalent after Trans-PRK
Optometry is performed using a computerized optometre. The spherical equivalent (SE) was calculated using the formula DS+DC/2, where DS denotes the diopter sphere and DC denotes the diopter cylinder.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start18 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongyang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gengmin Tong, Dongyang People's Hospital
- Investigators
- Guangjin Zhao, Study director, Dongyang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393855
- Sponsor's protocol ID
- BCLTPRK
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tong G, Jin Y, Zhou H, Jin Y. Base curves of bandage contact lenses and their effects on post Trans-PRK vision and pain: the study protocol for a randomized clinical trial. Trials. 2025 Sep 25;26(1):357. doi: 10.1186/s13063-025-09115-y.
PubMed 40999507
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Base Curves of Bandage Contact Lenses and Their Effects on Post Transepithelial Photorefractive Keratectomy (Trans-PRK) Vision and Pain： A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06393855
- Acronym / sponsor ID
- BCLTPRK
- Conditions
- Myopia
- Keywords
- Transepithelial photorefractive keratectomy, High Myopia, bandage contact lenses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dongyang People's HospitalUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 May 2024 (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.
The objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following Trans-PRK in patients characterized by steep corneas and high myopia.
Detailed description
Comparing two kind of bandage lenses in the contralateral eyes of the same individual following Trans-PRK may enable the derivation of reliable conclusions regarding the optimal choice for bandage lenses after Trans-PRK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contact lens with 8.4-mm base curve in right eye | Experimental | Procedure: single-step Trans-PRK, Behavioral: Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye.A contact lens placed on the cornea after the single-step Trans-PRK，with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye |
| contact lens with 8.8-mm base curve in right eye | Experimental | Procedure: single-step Trans-PRK, Behavioral: Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye.A contact lens placed on the cornea after the single-step Trans-PRK，with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Spherical equivalent refractive error between -6.00 and -8.00 D in either eye.
- Astigmatism of no more than 2.0 D in either eye.
- Best spectacle-corrected visual acuity (BCVA) according to the logarithm of the Minimum angle of resolution (logMAR) scale of 0 or better in both eyes.
- Willing and able to participate in all required activities of the study.
Key exclusion criteria (8 listed)
- Diabetes mellitus.
- Systemic connective tissue disease.
- Cardiovascular disease, epilepsy.
- Eyelid abnormalities.
- Corneal disease.
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 Trans-PRKBoth eyes were treated consecutively in each patient by single-step Trans-PRK performed by SCHWIND Amaris 500 S excimer laser platform (SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany). Topical Proparacaine Hydrochloride Eye Drops 0.5% (Alcaine, Alcon, Fort Worth, TX, USA) were used to anesthetize the eyes, and use povidone-iodine to disinfect the eyelid skin. After a lid speculum had been inserted, and the other eye was blocked. Epithelial and stromal ablations were performed using a single continuous laser shooting session on an excimer laser platform. After the appeals step, Mitomycin C 0.02 % was applied to the stromal surface for 20 s, then rinse with cold salt water. | Procedure or surgery | contact lens with 8.4-mm base curve in right eye, contact lens with 8.8-mm base curve in right eye |
| Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye.After surgery. A contact lens placed on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye. | Behavioural | contact lens with 8.4-mm base curve in right eye |
| Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye.After surgery. A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye. | Behavioural | contact lens with 8.8-mm base curve in right eye |
Primary outcome
Early postoperative uncorrected visual acuity
Time frame: 14 days
All visual acuity measurements were performed using a standard logarithmic eye chart
3 secondary outcomes
re-epithelialization after Trans-PRK
Time frame: 1 week
postoperative pain score after Trans-PRK
Time frame: 2 weeks
spherical equivalent after Trans-PRK
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40999507Tong G, Jin Y, Zhou H, Jin Y. Base curves of bandage contact lenses and their effects on post Trans-PRK vision and pain: the study protocol for a randomized clinical trial. Trials. 2025 Sep 25;26(1):357. doi: 10.1186/s13063-025-09115-y.
- Individual participant dataSharing planned: No
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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.
Guangjin Zhao study director
Dongyang People's Hospital
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 Trans-PRK, Placing a bandage contact lens on the cornea, with an 8.4-mm base curve in right eye and one with an 8.8-mm base curve in the left eye. and Placing a bandage contact lens on the cornea,A contact lens placed on the cornea, with an 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye. in people with Myopia, run by Dongyang People's Hospital at 1 site in China.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gengmin Tong (+8613588649648, fkstrer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative uncorrected visual acuity (time frame: 14 days). 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 NCT06393855, which also lists 1 linked publication.
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 11 Jul 2024.