Dongyang People's Hospital
Dongyang, Zhejiang, 322100, China
Location status: Recruiting
Recruiting
NCT Number: NCT06393855
Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
single-step Trans-PRK
ProcedureBoth 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.
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.
BehavioralAfter 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.
BehavioralAfter 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.
Primary outcomes
-
Early postoperative uncorrected visual acuity
Time frame: 14 days
All visual acuity measurements were performed using a standard logarithmic eye chart
Secondary outcomes
-
re-epithelialization after Trans-PRK
Time frame: 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).
-
postoperative pain score after Trans-PRK
Time frame: 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
-
spherical equivalent after Trans-PRK
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Dongyang People's Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- May 1, 2024
- Registry last updated
- Jul 11, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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