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.

Study Overview

• Status: Completed
• Conditions: Soft Contact Lenses
• Intervention / Treatment: Device: hydrogel soft contact lens

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10320
      • Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 )

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Tri Rahayu, MD, Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): January 28, 2025
• Study Completion (Actual): August 28, 2025

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: soft contact lens; conjunctival hyperemia; image J analysis; efron degree system
• Other Study ID Numbers: 19-02-0138; Faculty of Medicine, Universit (Other Identifier: Faculty of Medicine, Universitas Indonesia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to patient privacy considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes