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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06393855
Other study ID # BCLTPRK
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Dongyang People's Hospital
Contact Gengmin Tong
Phone +8613588649648
Email fkstrer@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
single-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.
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.
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.
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.

Locations

Country Name City State
China Dongyang People's Hospital Dongyang Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Dongyang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early postoperative uncorrected visual acuity All visual acuity measurements were performed using a standard logarithmic eye chart 14 days
Secondary 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=pa×b). 1 week
Secondary 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
Secondary 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
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