Completed

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

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Study Aim

This study aims to assess the level of conjunctival inflammation in soft contact lens wearers using Image J Analysis and Efron Degree System.

What is being tested

hydrogel soft contact lens

Device
Who is being recruted

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: March 2019
See protocol details

Summary

Principal SponsorIndonesia University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2019

Actual date on which the first participant was enrolled.

This study focuses on individuals with myopia, or nearsightedness, who are new to soft contact lenses (SCL). The main goal is to understand how soft contact lenses might affect the eye, specifically looking at conjunctival inflammation, which is redness or swelling of the thin tissue lining the white part of the eye. Participants are asked to wear soft contact lenses for 14 days, a period during which the study aims to gather valuable insights into how soft contact lenses might impact eye health in new users. During the study, participants undergo slit lamp examinations, a common eye test that allows a detailed look at the eye. These examinations are conducted before they start wearing soft contact lenses, and then again on the 7th and 14th day of wearing them. The results of these examinations are analyzed using two methods: the Efron Degree System (EDS) and ImageJ, a software tool for image analysis. By comparing these two methods, the study aims to evaluate how effectively they can assess any changes in conjunctival inflammation over the course of soft contact lens use.

Official TitleConformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analysis and Efron Degree System
NCT07290829
Principal SponsorIndonesia University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Jakarta, IndonesiaOpen Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia in Google Maps
CompletedOne Study Center