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

NCT07290829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

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 )

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Tri Rahayu, MD · Dr Cipto Mangunkusumo General Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2025-01-28
Completion
2025-08-28
FDA Device
Yes

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290829 on ClinicalTrials.gov