Soft Contact LensesNCT07290829
Conformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analysis and Efron Degree System
A study testing hydrogel soft contact lens in people with Soft Contact Lenses, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Soft Contact Lenses
- What is being tested?
- hydrogel soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Mar 2019to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
Jakarta, DKI Jakarta, 10320
About this study
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.
Read the 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.
- Conditions
- Soft Contact Lenses
- Being tested
- hydrogel soft contact lens
- Keywords
- soft contact lens, conjunctival hyperemia, image J analysis, efron degree system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrogel soft contact lensDevice
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 )
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: hydrogel soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on day 0 (before using SCL), day 7, and day 14
Image J analysis of hyperemia degree
Vascular density (%area) and Vascular diameter (μm )
Measured: on day 0 (before using SCL), day 7, and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start28 Mar 2019
- Primary completion28 Jan 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Contact LensesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Tri Rahayu, SpM(K), FIACLE, Universitas Indonesia
- Investigators
- Tri Rahayu, MD, Principal investigator, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290829
- Sponsor's protocol ID
- 19-02-0138
- Other IDs
- Faculty of Medicine, Universit
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared due to patient privacy considerations
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analysis and Efron Degree System
- ClinicalTrials.gov ID
- NCT07290829
- Acronym / sponsor ID
- 19-02-0138
- Conditions
- Soft Contact Lenses
- Keywords
- soft contact lens, conjunctival hyperemia, image J analysis, efron degree system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperemia evaluation of soft contact lens wearer | Experimental | Device: hydrogel soft contact lensHyperemia evaluation of soft contact lens wearer on day 0 (before using SCL), day 7, and day 14 of wearing SCL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrogel soft contact lensThis 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 ) | Device | Hyperemia evaluation of soft contact lens wearer |
Primary outcome
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
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient privacy considerations
Related trials for Soft Contact Lenses
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Smart Soft Contact Lenses for Monitoring Glaucoma
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Contact Lenses to Slow Myopia Progression in Adults
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Management of Myopia in University Students Using Dual Focus Soft Contact Lenses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tri Rahayu, MD principal investigator
Dr Cipto Mangunkusumo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrogel soft contact lens in people with Soft Contact Lenses, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efron degree system for hyperemia degree (time frame: on day 0 (before using SCL), day 7, and day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.