NCT07290829

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Soft Contact Lenses

Interventions

Type	Name	Description
DEVICE	hydrogel soft contact lens	This study aim to analyze the conformity of hyperemia when evaluated by ophthalmologist using the Efron degree system compared to evaluation by a computerized model (Image J analysis )

Timeline

• Start date: 2019-03-28
• Primary completion: 2025-01-28
• Completion: 2025-08-28
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated device study