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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07290829
Enrollment
52
Registered
2025-12-18
Start date
2019-03-28
Completion date
2025-08-28
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Contact Lenses

Keywords

soft contact lens, conjunctival hyperemia, image J analysis, efron degree system

Brief 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.

Interventions

DEVICEhydrogel 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 )

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

Conjunctival inflammation degree evaluation was done with taking picture of conjunctiva using slit lamp by lead researcher. Picture was taken on day 0 (before using SCL), day 7, and day 14 of wearing SCL. Pictures then were analyzed with Efron Degree System (EDS) by 2 evaluators (both were ophthalmologist consultants) and with ImageJ application by lead researcher. ImageJ analysis was done to decide conjunctival vascular diameter and density. EDS evaluator did not know the results of the assessment with ImageJ and vice versa.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efron degree system for hyperemia degreeon day 0 (before using SCL), day 7, and day 14Hyperemia grade based on Efron degree system, identified by percentage of hyperemia on the bulbar dan limbal conjunctiva * Normal * Trace * Mild * Moderate * Severe
Image J analysis of hyperemia degreeon day 0 (before using SCL), day 7, and day 14Vascular density (%area) and Vascular diameter (μm )

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026