Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
June 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 11, 2024
July 1, 2024
1.5 years
April 22, 2024
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early postoperative uncorrected visual acuity
All visual acuity measurements were performed using a standard logarithmic eye chart
14 days
Secondary Outcomes (3)
re-epithelialization after Trans-PRK
1 week
postoperative pain score after Trans-PRK
2 weeks
spherical equivalent after Trans-PRK
1 week
Study Arms (2)
contact lens with 8.4-mm base curve in right eye
EXPERIMENTALA 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
EXPERIMENTALA 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
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diabetes mellitus.
- Systemic connective tissue disease.
- Cardiovascular disease, epilepsy.
- Eyelid abnormalities.
- Corneal disease.
- Glaucoma.
- A history of ocular disease.
- Noncompliance with measurement at enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongyang People's Hospital
Dongyang, Zhejiang, 322100, China
Related Publications (1)
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.
PMID: 40999507DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guangjin Zhao
Dongyang People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 22, 2024
First Posted
May 1, 2024
Study Start
June 18, 2024
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share