An interventional study of single-step Trans-PRK and 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. in Myopia, sponsored by Dongyang People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Dongyang People's Hospital · Not applicable, Interventional, and Treatment
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 36 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Dongyang People's Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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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.
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
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 8.8-mm base curve in right eye and one with an 8.4-mm base curve in the left eye
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.
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.
Early postoperative uncorrected visual acuity
All visual acuity measurements were performed using a standard logarithmic eye chart
Time frame: 14 days
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).
Time frame: 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
Time frame: 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.
Time frame: 1 week
Plan to share: No
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Dongyang People's Hospital