Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain
- Conditions
- Myopia
- Interventions
- Procedure: single-step Trans-PRKBehavioral: 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: 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.
- Registration Number
- NCT06393855
- Lead Sponsor
- Dongyang People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
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.
Diabetes mellitus.
Systemic connective tissue disease.
Cardiovascular disease, epilepsy.
Eyelid abnormalities.
Corneal disease.
Glaucoma.
A history of ocular disease.
Noncompliance with measurement at enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description contact lens with 8.4-mm base curve in right eye single-step Trans-PRK 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 8.4-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. 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 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 contact lens with 8.8-mm base curve in right eye single-step Trans-PRK 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
- Primary Outcome Measures
Name Time Method Early postoperative uncorrected visual acuity 14 days All visual acuity measurements were performed using a standard logarithmic eye chart
- Secondary Outcome Measures
Name Time Method postoperative pain score after Trans-PRK 2 weeks 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
re-epithelialization after Trans-PRK 1 week 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).
spherical equivalent after Trans-PRK 1 week 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.
Trial Locations
- Locations (1)
Dongyang People's Hospital
🇨🇳Dongyang, Zhejiang, China