MyopiaBLINK2NCT04080128

Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control

An observational study of Myopia, run by Ohio State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Contact lenses
Type of treatment: Medical device
How many people: 248 participants
Where: 2 sitesUnited States
Study dates: 9 Sep 2019to 4 Jan 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 15 years
All sexes
Healthy volunteers accepted
Child

Study population: Only those participants in the original BLINK Study who have consented to continue will be enrolled in BLINK2.

Who may be able to join

Participants in the BLINK Study

Who cannot join

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ohio State University
Columbus, Ohio, 43210
University of Houston
Houston, Texas, 77204

Other trials in United States

About this study

Official title: Examination of Myopia Progression and Consequences and Mechanisms of Soft Bifocal Contact Lens Myopia Control

This project intends to provide important, previously unmet answers regarding biological associations with myopia (nearsightedness) progression in order to improve the ability to predict patients who are most likely to benefit from myopia control, as well as questions frequently posed by patients and practitioners about the side effects, mechanism, and discontinuation of soft bifocal contact lens myopia control. The first three aims examine the association between biological variables that can be measured non-invasively and myopia progression, and they will be conducted regardless of the outcome of the currently in progress BLINK Study. The last three specific aims will be conducted if soft bifocal contact lenses slowed myopia progression by 30% or more in the BLINK Study, and they can be investigated with very few additional measurements.

Read the detailed description

The primary goal of the BLINK2 Study is to determine correlates of myopia progression using non-invasive measurement of biomarkers, such as choroidal thickness and intrinsically photosensitive retinal ganglion cell-mediated pupil function, and outdoor light exposure in children. If multifocal contact lenses slow the progression of myopia by 30 percent or more compared to single vision contact lenses during the BLINK Study, the investigators will also answer important questions about the consequences and mechanism of the treatment effect, such as whether multifocal contact lens wear alters accommodative function and whether or not the treatment benefit is transient. Specifically, the investigators will investigate whether myopia progression is slowed or simply delayed by multifocal contact lens wear and whether there is a rebound in myopia progression, an increase in progression rate, after discontinuation of multifocal contact lenses. The investigators will identify myopic children who will most benefit from myopia control by determining those who are most likely to progress, thereby maximizing the potential for benefit and minimizing risk. The investigators will accomplish this goal by investigating the effect on progression of the most important ocular and environmental risk factors recently hypothesized to control eye growth. The project will collect the most extensive longitudinal dataset ever on choroidal thickness in childhood myopia. The investigators will test the important question of whether time outdoors and light exposure influence myopia progression after onset in addition to whether these affects are mediated by intrinsically photosensitive retinal ganglion cells. If soft multifocal contact lenses show a clinically meaningful slowing of myopia progression, we will also answer important questions asked routinely by our clinical colleagues. The investigators will know the accommodative effect of multiple years of multifocal contact lens wear in children, the investigators will know if multifocal contact lenses slow or simply delay myopia progression, and the investigators will know whether myopia progression increases following discontinuation of soft multifocal contact lens wear. Answers to questions addressed by this proposal could improve care for 60 million myopic children in the United States. While the consequences of ordinary myopia are rarely sight-threatening, the quality of life for myopic patients is negatively affected and the health care costs to treat myopia are approximately 4.6 billion dollars in 1990 US dollars. The National Eye Institute recognizes the need to evaluate the efficacy of potential treatments for delaying the onset or for slowing the progression of myopia, such as lenses that alter peripheral defocus. The BLINK2 Study seeks to maximize benefit while lowering the risk of multifocal contact lens wear for myopia control while answering important scientific and clinical questions about the consequences and mechanism of myopia progression, a problem that affects many people in the United States.

Conditions: Myopia
Being tested: Contact lenses
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contact lensesDevice
2.50 D multifocal contact lens years 1 and 2. Year 3 all wear a single vision contact lens.

Study groups in NCT04080128
Study group	Role	What they receive
Contact lens		The first two years of the study all participants will wear +2.50 D multifocal contact lenses. The last year of the study, all subjects will be wearing single vision contact lenses. Receives: Device: Contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length
test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with the outcome of greater axial elongation (eye growth)
The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.
Measured: Three years
The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in Axial Length
test the hypothesis that less ipRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient) as measured at the Baseline BLINK 2 is associated with greater axial elongation (eye growth) over three years
The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.
Measured: Three years
The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length
test the hypothesis that exposure to light levels over 1000 lux as measured at the Baseline BLINK2 visit is associated with less axial elongation (eye growth) over three years
The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.
Measured: Three years
Three-year Choroidal Thickness Change
The three-year change from baseline to three years for choroidal thickness.
Measured: 3 years
Duration of Exposure to Light Levels Exceeding 1000 Lux at Baseline
Baseline light exposure as measured by minutes at light levels over 1000 lux. Light exposure was monitored using the Actiwatch2 (Phillips Respironics), a light-sensing and logging watch worn on the wrist. Participants wore the device for a 1 week period to monitor environmental light exposure. The illuminance was measured in lux every minute. Data were scrubbed of periods where the watch was not worn or other artifacts. Light levels over 1000 lux were added to determine time outdoors in minutes.
Measured: Baseline
Baseline iPRGC Activity
Baseline iPRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient). The Blue Decay Coefficient represents the rate at which the pupil redilates in the dark after exposure to multiple 5-second pulses of red and blue light. The redilation data are fit by an exponential decay function eβt where t is time in seconds and the coefficient β is the natural log of the percent change in pupil diameter per second. Values range from -0.30 to -0.01. More positive values represent slower pupil redilation and are associated with greater, potentially beneficial ipRGC activity.
Measured: Baseline

Secondary outcomes (7)

Accommodative Amplitude
Testing the hypothesis that long-term soft bifocal contact lens wear does not alter accommodative amplitude. This hypothesis predicts that at the baseline BLINK2 Study visit, the accommodative amplitude will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study (NCT02255474). Assessed data from the beginning of the BLINK Study up to the BLINK2 Study Baseline Visit approximately 4.7 years, BLINK2 Study Baseline Visit reported
Measured: Baseline
Lag of Accommodation
Testing the hypothesis that long-term soft bifocal contact lens wear does not alter accommodative lag. This hypothesis predicts that at the baseline BLINK2 Study visit, the accommodative lag will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study (NCT02255474). Assessed data from the beginning of the BLINK Study up to the BLINK2 Study Baseline Visit approximately 4.7 years, BLINK2 Study Baseline Visit reported.
Measured: Baseline
Accommodative Facility
Testing the hypothesis that long-term soft bifocal contact lens wear does not alter accommodative facility. This hypothesis predicts that at the baseline BLINK2 Study visit, the accommodative lag will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study (NCT02255474). Assessed data from the beginning of the BLINK Study up to the BLINK2 Study Baseline Visit approximately 4.7 years, BLINK2 Study Baseline Visit reported.
Measured: Baseline
Slowing of Myopia Progression - Axial Length
Test the hypothesis that wearing +2.50 D multifocal contact lenses slow rather than merely delay myopia progression. This null hypothesis predicts that during the first two years of the BLINK2 Study, when all subjects will wear +2.50 D multifocal contact lenses, axial length elongation at the same rate regardless of original lens assignment (i.e., +2.50 D multifocal lenses, +1.50 D multifocal lenses, SVLs). Alternatively, faster myopia progression in subjects originally fitted with soft bifocal contact lenses compared to single vision contact lenses would indicate a delay in myopia progression rather than a permanent treatment benefit. Measured as the change the baseline BLINK2 visit to the 2 year visit on the IOLMaster which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal.
Because the exposures before the baseline visit were part of NCT02255474 immediately before this cohort, the original groups were analyzed.
Measured: Two year change (Baseline to 2-Year visit)
Rebound of Progression - Axial Length
The investigators will test the hypothesis that there is no increase in myopia when switching from +2.50 D multifocal contact lenses to single vision contact lenses in Year 2 of the BLINK2 observational study. This hypothesis predicts that the progression of myopia during the last year of follow-up when all subjects will switch to single vision contact lenses, will be similar to myopia progression during the first two years when all subjects wore multifocal contact lenses. Alternatively, faster progression after switching to single vision contact lens wear indicates a "rebound" of myopia progression.
This aim was specifically designed to measure what happened between the 2nd and 3rd annual visit which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal. Because the entire cohort was wearing the same contact lens, it uses all participants together.
Measured: One year change (2-year visit to 3-year visit)
Rebound of Progression - Myopia Progression
The investigators will test the hypothesis that there is no increase in myopia, as measured by the change in the spherical equivalent, when switching from +2.50 D multifocal contact lenses to single vision contact lenses in Year 2 of the BLINK2 observational study. This hypothesis predicts that the progression of myopia during the last year of follow-up when all subjects will switch to single vision contact lenses, will be similar to myopia progression during the first two years when all subjects wore multifocal contact lenses. Alternatively, faster progression after switching to single vision contact lens wear indicates a "rebound" of myopia progression.
This aim was specifically designed to measure what happened between the 2nd and 3rd annual visit which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal. Because the entire cohort was wearing the same contact lens, it uses all participants together.
Measured: One year change (2-year visit to 3-year visit)
Slowing of Myopia Progression - Myopia Progression
Test the hypothesis that wearing +2.50 D multifocal contact lenses slow rather than merely delay myopia progression. This null hypothesis predicts that during the first two years of the BLINK2 Study, when all subjects will wear +2.50 D multifocal contact lenses, participants will have myopia progression, as measured by spherical equivalent, at the same rate regardless of original lens assignment (i.e., +2.50 D multifocal lenses, +1.50 D multifocal lenses, SVLs). Alternatively, faster myopia progression in those with soft bifocal contact lenses compared to SVLs would indicate a delay in myopia progression rather than a permanent treatment benefit.
Measured between Baseline and Year 2 of the BLINK2 Study which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal.
Because the exposures before the baseline visit were part of NCT02255474 immediately before this cohort, the original groups were analyzed.
Measured: Two year change (Baseline visit to 2-year visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 20194 Jan 2024

First posted6 Sep 2019
Study start9 Sep 2019
Primary completion4 Jan 2024
Study completion4 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04080128
Sponsor's protocol ID: UG1EY023206
Acronym: BLINK2
Status last verified: Mar 2026
First submitted: 27 Aug 2019
Last updated: 2 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Chandler MA, Robich ML, Jordan LA, Mutti DO, Berntsen DA, Fenton R, Day E, Walline JJ; BLINK2 Study Group. Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial. Optom Vis Sci. 2023 Jul 1;100(7):425-431. doi: 10.1097/OPX.0000000000002040. Epub 2023 Jun 24.
PubMed 37369096

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of Myopia Progression and Consequences and Mechanisms of Soft Bifocal Contact Lens Myopia Control
ClinicalTrials.gov ID: NCT04080128
Acronym / sponsor ID: BLINK2 / UG1EY023206
Conditions: Myopia
Study type: Observational
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Collaborators: University of Houston
Study start: 9 Sep 2019 (actual)
Primary completion: 4 Jan 2024 (actual)
Study completion: 4 Jan 2024 (actual)
First posted: 6 Sep 2019 (actual)
Results: Posted 6 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Contact lens	–	Device: Contact lensesThe first two years of the study all participants will wear +2.50 D multifocal contact lenses. The last year of the study, all subjects will be wearing single vision contact lenses.

Who may qualify

Ages: 10 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Only those participants in the original BLINK Study who have consented to continue will be enrolled in BLINK2.

Key inclusion criteria (1 listed)

Participants in the BLINK Study

Key exclusion criteria (1 listed)

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
Contact lenses2.50 D multifocal contact lens years 1 and 2. Year 3 all wear a single vision contact lens.	Device	Contact lens

Primary outcome

The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length
Time frame: Three years
test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with the outcome of greater axial elongation (eye growth) The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.
The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in Axial Length
Time frame: Three years
test the hypothesis that less ipRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient) as measured at the Baseline BLINK 2 is associated with greater axial elongation (eye growth) over three years The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.
The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length
Time frame: Three years
test the hypothesis that exposure to light levels over 1000 lux as measured at the Baseline BLINK2 visit is associated with less axial elongation (eye growth) over three years The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.
Three-year Choroidal Thickness Change
Time frame: 3 years
The three-year change from baseline to three years for choroidal thickness.
Duration of Exposure to Light Levels Exceeding 1000 Lux at Baseline
Time frame: Baseline
Baseline light exposure as measured by minutes at light levels over 1000 lux. Light exposure was monitored using the Actiwatch2 (Phillips Respironics), a light-sensing and logging watch worn on the wrist. Participants wore the device for a 1 week period to monitor environmental light exposure. The illuminance was measured in lux every minute. Data were scrubbed of periods where the watch was not worn or other artifacts. Light levels over 1000 lux were added to determine time outdoors in minutes.
Baseline iPRGC Activity
Time frame: Baseline
Baseline iPRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient). The Blue Decay Coefficient represents the rate at which the pupil redilates in the dark after exposure to multiple 5-second pulses of red and blue light. The redilation data are fit by an exponential decay function eβt where t is time in seconds and the coefficient β is the natural log of the percent change in pupil diameter per second. Values range from -0.30 to -0.01. More positive values represent slower pupil redilation and are associated with greater, potentially beneficial ipRGC activity.

7 secondary outcomes

Accommodative Amplitude
Time frame: Baseline
Lag of Accommodation
Time frame: Baseline
Accommodative Facility
Time frame: Baseline
Slowing of Myopia Progression - Axial Length
Time frame: Two year change (Baseline to 2-Year visit)
Rebound of Progression - Axial Length
Time frame: One year change (2-year visit to 3-year visit)
Rebound of Progression - Myopia Progression
Time frame: One year change (2-year visit to 3-year visit)
Slowing of Myopia Progression - Myopia Progression
Time frame: Two year change (Baseline visit to 2-year visit)

Results and safety

Results posted to the registry on 6 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BLINK RCT Assignment: +2.50 D/Baseline to Year 2: +2.50 D Multifocal/Year 2 to 3: Single Vision CLs	78	72
BLINK RCT Assignment: +1.50 D/Baseline to Year 2: +2.50 D Multifocal/Year 2 to 3: Single Vision CLs	84	77
BLINK RCT Assignment: Single Vision/Baseline to Year 2:+2.50 D Multifocal/Year 2 to 3: Single Vision	86	86

Primary outcome: The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length

Time frame: Three years. Mean (Standard Deviation). Unit: mm axial length

Measure	Contact Lens n = 234
Value	0.18 (0.19)

Contact Lens: correlation coefficient: -0.26, p <0.001, Regression, Linear

Population analysed: Axial length average over right and left eye

Primary outcome: The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in Axial Length

Time frame: Three years. Mean (Standard Deviation). Unit: mm axial length

Measure	Contact Lens n = 230
Value	0.18 (0.18)

Contact Lens: correlation coefficient: -0.14, p = 0.04, correlation coefficient

Population analysed: Axial length average over right and left eye

Primary outcome: The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length

Time frame: Three years. Mean (Standard Deviation). Unit: mm axial length

Measure	Contact Lens n = 230
Value	0.18 (0.18)

Contact Lens: correlation coefficient: -0.14, p = 0.04, correlation coefficient

Population analysed: Axial length measured as the average of the right and left eye.

Primary outcome: Three-year Choroidal Thickness Change

Time frame: 3 years. Mean (Standard Deviation). Unit: microns

Measure	Contact Lens n = 234
Value	6.12 (33.73)

Population analysed: Right eye only

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Three years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
+2.50 D/+2.50 D Multifocal Contact Lens	4 of 78 (5.1%)	47 of 78 (60.3%)	0 of 78
+1.50 D/+2.50 D Multifocal Contact Lens	0 of 84 (0%)	56 of 84 (66.7%)	0 of 84
Single Vision Contact Lenses (SVL)/+2.50 D MCL	1 of 86 (1.2%)	56 of 86 (65.1%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37369096Chandler MA, Robich ML, Jordan LA, Mutti DO, Berntsen DA, Fenton R, Day E, Walline JJ; BLINK2 Study Group. Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial. Optom Vis Sci. 2023 Jul 1;100(7):425-431. doi: 10.1097/OPX.0000000000002040. Epub 2023 Jun 24.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Jeffrey J Walline, OD PhD principal investigator

The Ohio State University College of Optometry

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia, run by Ohio State University at 2 sites in United States.

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 1 inclusion and 1 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length (time frame: Three years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080128, which also lists 1 linked publication.

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 2 Jun 2026.