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

NCT ID: NCT07290829

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2025-08-28

Brief Summary

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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

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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

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Soft Contact Lenses

Keywords

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soft contact lens conjunctival hyperemia image J analysis efron degree system

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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Hyperemia evaluation of soft contact lens wearer

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

Group Type EXPERIMENTAL

hydrogel soft contact lens

Intervention Type DEVICE

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 )

Interventions

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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 )

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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dr. Tri Rahayu, SpM(K), FIACLE

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tri Rahayu, MD

Role: PRINCIPAL_INVESTIGATOR

Dr Cipto Mangunkusumo General Hospital

Locations

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Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Faculty of Medicine, Universit

Identifier Type: OTHER

Identifier Source: secondary_id

19-02-0138

Identifier Type: -

Identifier Source: org_study_id