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

NCT07290829 | Completed FDA Device

• 2 other identifiers: 19-02-0138Faculty of Medicine, Universit
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Contact Lenses

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Hyperemia evaluation of soft contact lens wearer

EXPERIMENTAL

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

Interventions

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 )

Hyperemia evaluation of soft contact lens wearer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta, DKI Jakarta, 10320, Indonesia

Location

Study Officials

• Tri Rahayu, MD

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: March 28, 2019
• Primary Completion: January 28, 2025
• Study Completion: August 28, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)