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Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain

Base Curves of Bandage Contact Lenses and Their Effects on Post Transepithelial Photorefractive Keratectomy (Trans-PRK) Vision and Pain: A Prospective Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06393855
Enrollment
36
Registered
2024-05-01
Start date
2024-06-18
Completion date
2025-12-31
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Transepithelial photorefractive keratectomy, High Myopia, bandage contact lenses

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.

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.

Interventions

PROCEDUREsingle-step Trans-PRK

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.

BEHAVIORALPlacing 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.

BEHAVIORALPlacing 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.

Sponsors

Dongyang People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Early postoperative uncorrected visual acuity14 daysAll visual acuity measurements were performed using a standard logarithmic eye chart

Secondary

MeasureTime frameDescription
re-epithelialization after Trans-PRK1 weekA 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).
postoperative pain score after Trans-PRK2 weeksPatients 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
spherical equivalent after Trans-PRK1 weekOptometry 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.

Countries

China

Contacts

Primary ContactGengmin Tong
fkstrer@163.com+8613588649648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026