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OpenTrials
Completed

NCT Number: NCT07290829

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

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.

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Key information

Conditions

Soft Contact Lenses

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jakarta, DKI Jakarta, 10320, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydrogel soft contact lens

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 )

Primary outcomes

  1. Efron degree system for hyperemia degree

    Time frame: on day 0 (before using SCL), day 7, and day 14

    Hyperemia grade based on Efron degree system, identified by percentage of hyperemia on the bulbar dan limbal conjunctiva

    • Normal
    • Trace
    • Mild
    • Moderate
    • Severe

  2. Image J analysis of hyperemia degree

    Time frame: on day 0 (before using SCL), day 7, and day 14

    Vascular density (%area) and Vascular diameter (μm )

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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