AmblyopiaNCT04785690
CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY
A study testing CureSight and Patching in people with Amblyopia, run by NovaSight at 1 site in United States.
Trial summary
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- CureSight and Patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 1 May 2023
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The following criteria must be met for a child to be enrolled in the study:
- Age 4 to <9 years male and female
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- Criteria for strabismic amblyopia: At least one of the following must be met:
- Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5 PD by SPCT at near fixation
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
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- Criteria for anisometropia: At least one of the following criteria must be met:
- ≥1.00 D difference between eyes in spherical equivalent
- ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
- Criteria for strabismus are met (see above)
- ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- Amblyopia associated with anisometropia, strabismus or both meeting at least one of the following conditions:
- Newly diagnosed amblyopia (i.e. no prior treatment)
- Non-adherence to amblyopia treatment with no treatment administered for a minimum of 8 weeks prior to the Screening Visit
- Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months) if any of the following are true:
- Hypermetropia of 2.50 D or more by spherical equivalent (SE)
- Myopia of amblyopic eye of 0.50D or more SE
- Astigmatism of 1.00D or more
- Anisometropia of more than 0.50D SE
- NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator's discretion, but must follow the study-specified prescribing guidelines, as detailed below.
- Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
- SE must be within 0.50D of fully correcting the anisometropia.
- SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
- Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
- Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is >1.00D.
- Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
- Spectacle correction meeting the above criteria must be worn:
- For at least 16 weeks OR until distance VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
- For determining VA stability (non-improvement):
- The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
- The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
- Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.
- VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the Lea symbol per ATS VA protocol for children < 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
- Visual acuity in the amblyopic eye 20/32 to 20/100 inclusive
- Best-corrected dominant-eye VA meeting the following criteria:
- If age 4, 20/40 or better by Lea symbol per ATS
- If age 5 and older, 20/32 or better by ATS-HOTV using LEA symbols for age <7 and Lea numbers for > 7 years
- Interocular difference ≥ 2 logMAR lines (Lea symbol per ATS)
- Heterotropia with a near deviation of <5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >4∆ are not allowed because large magnitudes of the deviation would compromise successful alignment of the dichoptic stimuli.)
- Passing a dedicated 10 min in-clinic performance ability test to assure suitable eye tracking performance (validity of eye tracking data >90% and successful calibration process).
- Subjects and families eligible for clinic visits over duration of study.
- Subject in general good health and able, as per investigator decision, to comply with study visits and protocol procedures and wear refractive correction and has access to wireless internet at home which is able to support the CureSight treatment (loaned by sponsor) .
- Signed and dated informed consent form.
- Parent and participant understand and are willing to comply with study procedures and will be available for the duration of the study.
Who cannot join
- Myopia greater than -6.00 D. spherical equivalent in either eye.
- Known skin reactions to patch or bandage adhesives.
- Any other condition which could be a potential cause for reduced BCVA according to the investigator.
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
- History of low adherence with amblyopia treatment as assessed informally by the investigator.
- Subjects that do not wear their spectacles. (as assessed by investigator)
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- History of light-induced seizures.
- Wearing RGP contact lenses.
- Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
- Previous intraocular or refractive surgery.
- Any condition that prevents the subject from completing a continues 45-90 min. of treatment per day while seating in front of a near screen. Such as children who don't like or cannot watch TV/movies for more than 60 min every day according to the parent's report.
- Heterophoria with a total near deviation of ≥10Δ (measured by PACT).
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Pediatric Eye Center
Virginia Beach, Virginia, 23452
About this study
Official title: A Prospective, Multicenter, Randomized, Masked, Controlled Pivotal Trial to Assess the Safety and Effectiveness of an Eye-Tracking-Based Treatment for Amblyopia Under Binocular Conditions Versus the Standard of Care, Monocular Deprivation Treatment (Occlusive Patching)
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.
On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional)
Read more
Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.
All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks:
- Binocular treatment 90 minutes per day, 5 days per week
- Patching group: Patching 2 hours per day, 7 days per week.
Follow up visits
- 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel)
- Visit 2: 4 weeks ± 1 week
- Visit 3: 8 weeks ± 1 week
- Visit 4: 12 weeks ± 1 week
- Visit 5: 16 weeks ± 1 week (primary endpoint)
- Unmasking of primary outcome results
- For each individual subject, clinician's decision regarding:
Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age)
•Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes
Read the detailed description
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.
On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional)
Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.
All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks:
- Binocular treatment 90 minutes per day, 5 days per week
- Patching group: Patching 2 hours per day, 7 days per week.
Follow up visits
- 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel)
- Visit 2: 4 weeks ± 1 week
- Visit 3: 8 weeks ± 1 week
- Visit 4: 12 weeks ± 1 week
- Visit 5: 16 weeks ± 1 week (primary endpoint)
- Unmasking of primary outcome results
- For each individual subject, clinician's decision regarding:
Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age)
•Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes)
The call center will be comprised of NovaSight personnel, protected by a firewall. For the patching group subjects, the call center personnel will contact all subjects' guardians at 1 week (3 to 7 days) to encourage initial compliance with treatment.
For the CureSight treatment group, the call center will contact the subjects' guardians in order to:
- Assist first time setup at home over the phone
- Provide technical support by phone in case of system malfunction or any other query or problem appearing during treatment
- Respond to compliance notifications of the software and contact the subject's guardians when needed in order to encourage compliance
- Answer any questions that arise by the subjects or guardians.
Permission for such contacts will be included in the Informed Consent Form.
The call center personal will be exposed to the following details, contact information, email and phone number.
- Conditions
- Amblyopia
- Being tested
- CureSight, Patching
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CureSightDevice
Subjects assigned to the binocular treatment group will be prescribed the CureSight treatment to watch for 90 minutes per day, 5 days a week for 16 weeks for the total of 120 hours. Parents of subjects will be instructed that the 90 minutes of daily treatment should be completed in a single 90-minute session, but if this is not possible for whatever reason, the treatment may be divided into two shorter sessions totaling 90 minutes per day
PatchingDevice
Subjects assigned to the patching group will wear an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks. Parents of subjects will be instructed that the 2 hours of daily patching should be completed in a single 2-hour session, but if this is not possible for whatever reason, the treatment may be divided into shorter sessions totaling 2 hours.
Parents will be asked to complete a usage diary by manually recording the patch usage time on daily basis.
| Study group | Role | What they receive |
|---|---|---|
| CureSight | Experimental | eye-tracking-based Receives: Device: CureSight |
| Patching | Active comparator | occlusive deprivation Receives: Device: Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
mean change in amblyopic eye distance BCVA
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start31 Mar 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Crouch, MD, Principal investigator, Virginia Pediatric Eye Center 4665 South Blvd. Virginia Beach, VA 23452
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785690
- Sponsor's protocol ID
- NS-00706-R01
- Status last verified
- Aug 2023
- First submitted
- 3 Mar 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Masked, Controlled Pivotal Trial to Assess the Safety and Effectiveness of an Eye-Tracking-Based Treatment for Amblyopia Under Binocular Conditions Versus the Standard of Care, Monocular Deprivation Treatment (Occlusive Patching)
- ClinicalTrials.gov ID
- NCT04785690
- Acronym / sponsor ID
- NS-00706-R01
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NovaSightIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Mar 2021 (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.
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.
On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional)
Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.
All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks:
- Binocular treatment 90 minutes per day, 5 days per week
- Patching group: Patching 2 hours per day, 7 days per week.
Follow up visits
- 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel)
- Visit 2: 4 weeks ± 1 week
- Visit 3: 8 weeks ± 1 week
- Visit 4: 12 weeks ± 1 week
- Visit 5: 16 weeks ± 1 week (primary endpoint)
- Unmasking of primary outcome results
- For each individual subject, clinician's decision regarding:
Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age)
•Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes
Detailed description
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.
On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional)
Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.
All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks:
- Binocular treatment 90 minutes per day, 5 days per week
- Patching group: Patching 2 hours per day, 7 days per week.
Follow up visits
- 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel)
- Visit 2: 4 weeks ± 1 week
- Visit 3: 8 weeks ± 1 week
- Visit 4: 12 weeks ± 1 week
- Visit 5: 16 weeks ± 1 week (primary endpoint)
- Unmasking of primary outcome results
- For each individual subject, clinician's decision regarding:
Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age)
•Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes)
The call center will be comprised of NovaSight personnel, protected by a firewall. For the patching group subjects, the call center personnel will contact all subjects' guardians at 1 week (3 to 7 days) to encourage initial compliance with treatment.
For the CureSight treatment group, the call center will contact the subjects' guardians in order to:
- Assist first time setup at home over the phone
- Provide technical support by phone in case of system malfunction or any other query or problem appearing during treatment
- Respond to compliance notifications of the software and contact the subject's guardians when needed in order to encourage compliance
- Answer any questions that arise by the subjects or guardians.
Permission for such contacts will be included in the Informed Consent Form.
The call center personal will be exposed to the following details, contact information, email and phone number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.
| Arm | Type | Receives |
|---|---|---|
| CureSight | Experimental | Device: CureSighteye-tracking-based |
| Patching | Active comparator | Device: Patchingocclusive deprivation |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (45 listed)
- Age 4 to <9 years male and female
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- Amblyopia associated with anisometropia, strabismus or both meeting at least one of the following conditions:
- Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months) if any of the following are true:
- NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator's discretion, but must follow the study-specified prescribing guidelines, as detailed below.
Key exclusion criteria (12 listed)
- Myopia greater than -6.00 D. spherical equivalent in either eye.
- Known skin reactions to patch or bandage adhesives.
- Any other condition which could be a potential cause for reduced BCVA according to the investigator.
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
- History of low adherence with amblyopia treatment as assessed informally by the investigator.
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 |
|---|---|---|
| CureSightSubjects assigned to the binocular treatment group will be prescribed the CureSight treatment to watch for 90 minutes per day, 5 days a week for 16 weeks for the total of 120 hours. Parents of subjects will be instructed that the 90 minutes of daily treatment should be completed in a single 90-minute session, but if this is not possible for whatever reason, the treatment may be divided into two shorter sessions totaling 90 minutes per day | Device | CureSight |
| PatchingSubjects assigned to the patching group will wear an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks. Parents of subjects will be instructed that the 2 hours of daily patching should be completed in a single 2-hour session, but if this is not possible for whatever reason, the treatment may be divided into shorter sessions totaling 2 hours. Parents will be asked to complete a usage diary by manually recording the patch usage time on daily basis. | Device | Patching |
Primary outcome
best corrected visual acuity
Time frame: 16 weeks
mean change in amblyopic eye distance BCVA
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 8 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Eric Crouch, MD principal investigator
Virginia Pediatric Eye Center 4665 South Blvd. Virginia Beach, VA 23452
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CureSight and Patching in people with Amblyopia, run by NovaSight at 1 site 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 45 inclusion and 12 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 8 Aug 2023. 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 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?
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?
best corrected visual acuity (time frame: 16 weeks). 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 8 Aug 2023.