Conformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analysis and Efron Degree System

University of Indonesia (UI)

Status: Completed

Conditions: Soft Contact Lenses

Treatments: Device: hydrogel soft contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT07290829

Faculty of Medicine, Universit (Other Identifier)

19-02-0138

Details and patient eligibility

About

Soft Contact Lens (SCL) use all over the world is still increasing. Ocular surface inflammatory reaction is the most common risk of using SCL. Currently, the standard used to assess this complication is the Efron Degree System (EDS), but it has high variability due its subjectivity. ImageJ gives more objective result with conjunctival vasodilation and vascular density assessment, so that complication management can be given earlier.

Purpose: Evaluate the suitability of SDE with ImageJ analysis in assessing conjunctival hyperemia in SCL use within 2 weeks.

Full description

This is a paired prospective analytic study. Subjects with myopia who have not used SCL routinely before were instructed to use SCL for 14 days. Conjunctival inflammation were assessed with slit lamp examination before, at day 7, and day 14 of using SCL. Slit lamp pictures were analysed with EDS and ImageJ to be compared.

Enrollment: 52 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject with mild to moderate myopia (-0.50 to -6.00 D)
• age between 18-45 years old
• subject who refuse refractive correction with glasses or surgery
• patient with astigmatism refractive error no more than -1 Diopter

Exclusion criteria

• subject with previous intraocular surgery
• subject who is wearing SCL continuously
• subject with history of dry eyes, uveitis, glaucoma, or corneal and conjunctival disorders
• subject with history of allergic reaction to contact lens material or lens wetting solution used in this study
• subject with ongoing eye drop treatment
• female subject with ongoing pregnancy or on breastfeeding
• subject with too improper lens fitting
• subject who work around exposure of chemical substance, smoke, hazardous gas, or fire sparks

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

Hyperemia evaluation of soft contact lens wearer

Experimental group

Description:

Hyperemia evaluation of soft contact lens wearer on day 0 (before using SCL), day 7, and day 14 of wearing SCL

Treatment:

Device: hydrogel soft contact lens