MyopiaNCT05243836
S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children
A study testing S.T.O.P® F2, S.T.O.P® DT and MiSight® in people with Myopia, run by nthalmic Pty Ltd at 7 sites in 3 countries.
Trial summary
To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Myopia
- What is being tested?
- S.T.O.P® F2, S.T.O.P® DT and MiSight®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 4 Aug 2023to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 8-14.
- Have:
- Read the Informed Assent.
- Been explained the Informed Assent.
- Indicated an understanding of the Informed Assent.
- Signed the Informed Assent.
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- Have their parent / legal guardian:
- Read the Informed Consent.
- Been explained the Informed Consent.
- Indicated an understanding of the Informed Consent.
- Signed the Informed Consent.
- Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
- Along with their parent / legal guardian, agree to maintain the visit schedule .
- Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not > 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons.
- Possess wearable and visually functioning spectacles.
- Be in good general health, based on the parent's / legal guardian's knowledge.
- Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
- Meet the following criteria determined by cycloplegic autorefraction:
- Spherical equivalent between -0.75 to -4.00 D inclusive.
- Astigmatism ≥ -1.00 D.
- participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ -0.75 D is measured with subjective refraction.
- anisometropia ≤ 1.00 D.
Who cannot join
- Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
- Current or prior use of ANY form of myopia control, including but not limited to:
- Optical devices.
- Bifocal / multifocal spectacles of any type.
- Bifocal / multifocal contact lenses of any type.
- Orthokeratology of any type.
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- Pharmacological agents.
- European and Indian sites: Atropine.
- Chinese sites: Atropine with a concentration > 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
- Pirenzepine.
- Participant born earlier than 30 weeks or weighed < 1500 g at birth.
- Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
- A known allergy to sodium fluorescein, benoxinate, proparacaine, or tropicamide.
- Chinese sites: A known allergy to cyclopentolate.
- A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or any other recurrent ocular infections.
- Strabismus by cover test at distance (3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
- Known ocular or systemic disease, such as but not limited to:
- Diabetes.
- Graves' disease.
- Glaucoma.
- Uveitis.
- Scleritis.
- Auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
- Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
- Persistent pupillary membrane.
- Vitreous haemorrhage.
- Cataract.
- Central corneal scarring.
- Eyelid haemangiomas.
- Marfan's syndrome.
- Down's syndrome.
- Ehler's-Danlos syndrome.
- Stickler's syndrome.
- Ocular albinism.
- Retinopathy of prematurity.
- Keratoconus or irregular cornea.
- Biomicroscopic that contraindicate contact lens, such as but limited to:
- Neovascularisation or ghost vessels ≥ 1.5 mm in from limbus.
- Any active anterior segment disease that contraindicates safe contact lens wear.
- Clinically significant giant papillary conjunctivitis.
- Clinically significant abnormalities of the anterior segment, lids, conjunctiva, sclera, or associated structures.
- Allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule.
- The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
China3 sites
Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, 200031
Tianjin Medical University
Tianjin, Wuqing District, 300384
Wenzhou Medical University Eye Hospital
Wenzhou, Lucheng District, 325027
Spain3 sites
Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid
Madrid, Madrid, 28037
Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)
Santiago de Compostela, Galicia, 15899
Centre Universitari de la Visió
Terrassa, Barcelona, 08222
About this study
Official title: Contact Lenses Utilising S.T.O.P.® Technology Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children: A Three-year Prospective, Multi-centre, Controlled, Masked, Randomised, Non Inferiority Clinical Trial
To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.
Read the detailed description
Myopic children (8-14 years of age) will be randomly allocated to wear one of 3 contact lens options (MiSight®, S.T.O.P.®- F2 or S.T.O.P.®- DT) bilaterally on a daily wear basis. The overall trial duration, including follow-up period, is expected to be approximately 48 months. Each participant's duration is expected to be approximately 36 months.
The visits are Baseline / Fit, Dispensing, 1 week, 1 month, 6 months then visits every 6 months after.
All procedures performed at these visits are standard, non invasive clinical tests.
- Conditions
- Myopia
- Being tested
- S.T.O.P® F2, S.T.O.P® DT, MiSight®
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.T.O.P® F2Device
Ocufilcon D, 55% water
S.T.O.P® DTDevice
Ocufilcon D, 55% water
MiSight®Device
Omafilcon A (60% water)
| Study group | Role | What they receive |
|---|---|---|
| MiSight® | Active comparator | MiSight® Contact Lens (Omafilcon A, 60% water) Receives: Device: MiSight® |
| S.T.O.P® F2 | Experimental | S.T.O.P® F2 Contact Lens (Ocufilcon D, 55% water) Receives: Device: S.T.O.P® F2 |
| S.T.O.P® DT | Experimental | S.T.O.P® DT Contact Lens (Ocufilcon D, 55% water) Receives: Device: S.T.O.P® DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length
Difference in change from baseline in axial length between test and control contact lenses.
Measured: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Cycloplegic spherical equivalent autorefraction
Difference in change from baseline in spherical equivalent autorefraction between test and control contact lenses.
Measured: Baseline, 12 months, 24 months, 36 months
Secondary outcomes (21)
Visual performance as measured by high contrast visual acuity at 6 m
Differences in visual performance between test and control contact lenses
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale where a higher score indicates a better outcome
Differences in visual performance between test and control contact lenses
Measured: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
Differences in bulbar hyperemia grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
Differences in limbal hyperemia grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal neovascularization graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Differences in corneal neovascularization grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness
Differences in palpebral roughness grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Differences in corneal staining grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Differences in conjunctival staining grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal oedema graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased oedema
Differences in corneal oedema grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Blepharitis graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased blepharitis
Differences in blepharitis grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Meibomian gland dysfunction (MGD) graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased MGD
Differences in MGD grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal epithelial microcysts graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Differences in corneal epithelial microcysts grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens surface characteristics staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates worse contact lens surface characteristic.
Differences in contact lens surface characteristic grading between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens centration measured in mm
Differences in contact lens centration between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens primary gaze movement centration measured in mm where a higher value indicates increased movement in primary gaze
Differences in primary gaze movement between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens primary gaze lag centration measured in mm where a higher value indicates increased lag.
Differences in primary gaze lag between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens tightness measured as percentage where a higher percentage indicates a tighter lens
Differences in tightness between test and control contact lenses.
Measured: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Binocular vision as measured by heterophoria in prism diopters at 3 m
Differences in heterophoria at 3 m between test and control contact lenses.
Measured: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by heterophoria in prism diopters at 40 cm
Differences in heterophoria at 40 cm between test and control contact lenses.
Measured: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by monocular accommodative response in diopters at 40 cm
Differences in monocular accommodative response at 40 cm between test and control contact lenses.
Measured: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by monocular accommodative facility (+/-2.00 D flipper) in cycles per minute at 40 cm
Differences in monocular accommodative facility at 40 cm between test and control contact lenses.
Measured: 1 week, 6 months, 18 months, 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start4 Aug 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 441 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nthalmic Pty Ltd
- Sponsor type
- Research network
- Collaborators
- Brighten Optix Corporation
- Responsible party
- Sponsor
- Investigators
- Daniel Tilia, MOptom, PhD, Principal investigator, nthalmic Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243836
- Sponsor's protocol ID
- nthal2021-01
- Status last verified
- Jun 2026
- First submitted
- 17 Jan 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lenses Utilising S.T.O.P.® Technology Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children: A Three-year Prospective, Multi-centre, Controlled, Masked, Randomised, Non Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05243836
- Acronym / sponsor ID
- nthal2021-01
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 441 participants (estimated)
- Lead sponsor
- nthalmic Pty LtdResearch network
- Collaborators
- Brighten Optix Corporation
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Feb 2022 (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.
To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.
Detailed description
Myopic children (8-14 years of age) will be randomly allocated to wear one of 3 contact lens options (MiSight®, S.T.O.P.®- F2 or S.T.O.P.®- DT) bilaterally on a daily wear basis. The overall trial duration, including follow-up period, is expected to be approximately 48 months. Each participant's duration is expected to be approximately 36 months.
The visits are Baseline / Fit, Dispensing, 1 week, 1 month, 6 months then visits every 6 months after.
All procedures performed at these visits are standard, non invasive clinical tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MiSight® | Active comparator | Device: MiSight®MiSight® Contact Lens (Omafilcon A, 60% water) |
| S.T.O.P® F2 | Experimental | Device: S.T.O.P® F2S.T.O.P® F2 Contact Lens (Ocufilcon D, 55% water) |
| S.T.O.P® DT | Experimental | Device: S.T.O.P® DTS.T.O.P® DT Contact Lens (Ocufilcon D, 55% water) |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (22 listed)
- Be between 8-14.
- Have:
- Have their parent / legal guardian:
- Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
- Along with their parent / legal guardian, agree to maintain the visit schedule .
Key exclusion criteria (43 listed)
- Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
- Current or prior use of ANY form of myopia control, including but not limited to:
- Participant born earlier than 30 weeks or weighed < 1500 g at birth.
- Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
- A known allergy to sodium fluorescein, benoxinate, proparacaine, or tropicamide.
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 |
|---|---|---|
| S.T.O.P® F2Ocufilcon D, 55% water | Device | S.T.O.P® F2 |
| S.T.O.P® DTOcufilcon D, 55% water | Device | S.T.O.P® DT |
| MiSight®Omafilcon A (60% water) | Device | MiSight® |
Primary outcome
Axial Length
Time frame: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Difference in change from baseline in axial length between test and control contact lenses.
Cycloplegic spherical equivalent autorefraction
Time frame: Baseline, 12 months, 24 months, 36 months
Difference in change from baseline in spherical equivalent autorefraction between test and control contact lenses.
21 secondary outcomes
Visual performance as measured by high contrast visual acuity at 6 m
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale where a higher score indicates a better outcome
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal neovascularization graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal oedema graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased oedema
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Blepharitis graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased blepharitis
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Meibomian gland dysfunction (MGD) graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased MGD
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal epithelial microcysts graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens surface characteristics staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates worse contact lens surface characteristic.
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens centration measured in mm
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens primary gaze movement centration measured in mm where a higher value indicates increased movement in primary gaze
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens primary gaze lag centration measured in mm where a higher value indicates increased lag.
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Contact lens tightness measured as percentage where a higher percentage indicates a tighter lens
Time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Binocular vision as measured by heterophoria in prism diopters at 3 m
Time frame: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by heterophoria in prism diopters at 40 cm
Time frame: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by monocular accommodative response in diopters at 40 cm
Time frame: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by monocular accommodative facility (+/-2.00 D flipper) in cycles per minute at 40 cm
Time frame: 1 week, 6 months, 18 months, 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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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.
Daniel Tilia, MOptom, PhD principal investigator
nthalmic Pty Ltd
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S.T.O.P® F2, S.T.O.P® DT and MiSight® in people with Myopia, run by nthalmic Pty Ltd at 7 sites in 3 countries.
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 22 inclusion and 43 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: under way, not looking for participants, as of the sponsor's last update on 17 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 7 sites in China, Spain, India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Axial Length (time frame: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months). 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 17 Jun 2026.