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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-step Trans-PRK | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative uncorrected visual acuity | All visual acuity measurements were performed using a standard logarithmic eye chart | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 week |
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Inclusion Criteria:
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.
Exclusion Criteria:
Diabetes mellitus.
Systemic connective tissue disease.
Cardiovascular disease, epilepsy.
Eyelid abnormalities.
Corneal disease.
Glaucoma.
A history of ocular disease.
Noncompliance with measurement at enrollment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gengmin Tong | Contact | +8613588649648 | fkstrer@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guangjin Zhao | Dongyang People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongyang People's Hospital | Recruiting | Dongyang | Zhejiang | 322100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40999507 | Derived | 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. |
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|
| 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. | Behavioral | 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. | Behavioral | 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. |
|
| 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 | 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. | 1 week |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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