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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393855
• Other study ID #: BCLTPRK
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Myopia

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