Intermittent ExotropiaNCT07642934
A Comparative Study of the Efficacy of Myopia Control Lenses With Different Mechanisms on Controlling Myopia Progression in Patients With Intermittent Exotropia
A study testing DIMS glasses and DOT glasses in people with Intermittent Exotropia and Myopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The goal of this clinical trial is to compare the efficacy of myopia control lenses with different working principles in patients with intermittent exotropia aged 6 to 12 years. The main questions it aims to answer are: Are there any differences in the clinical outcomes of DIMS and DOT glasses between children with… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Intermittent Exotropia, Myopia
- What is being tested?
- DIMS glasses and DOT glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 May 2027
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants aged 6 to 12 years (6 ≤ age ≤ 12 years). Written informed consent from legal guardians is mandatory.
- Patients with basic-type intermittent exotropia (IXT) meeting all the following criteria:
- Intermittent or constant exotropia at the distance of 6 meters, and intermittent exotropia or esophoria at the near distance of 33 centimeters;
- Distance exodeviation ≥ 10 prism diopters (PD) measured via the prism and alternate cover test (PACT);
- The difference between near and distance deviation ≤ 10 PD.
- Based on cycloplegic spherical equivalent (SE), the myopic refractive error of both eyes ranges from -6.0 D to -0.5 D.
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- The logMAR value of monocular distance best-corrected visual acuity (BCVA) measured by the ETDRS chart is ≤ 0.2, and no amblyopia is present.
- Parents and children are willing to participate in this clinical trial and can complete the entire study protocol.
- Children have healthy eyes without organic ocular diseases.
Who cannot join
- Participants who have worn myopia control glasses or received other myopia interventions, including low-concentration atropine and phototherapy instruments, within the past 6 months (excluding DIMS and DOT glasses).
- Those with severe systemic diseases or cognitive impairment that hinders follow-up attendance and clinical examinations.
- 4. Subjects with astigmatism of ≥ 2 diopters (D) in either eye after cycloplegia; individuals enrolled in other interventional trials.
- 5. Patients with active ocular inflammation in either eye. 6. Those diagnosed with ocular diseases or presenting with clinically significant abnormalities on ophthalmic examinations.
- 7. Participants are currently receiving visual function training or other clinical interventions for intermittent exotropia.
- 8. Individuals who decline to complete the 1-year follow-up period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to compare the efficacy of myopia control lenses with different working principles in patients with intermittent exotropia aged 6 to 12 years. The main questions it aims to answer are:
Are there any differences in the clinical outcomes of DIMS and DOT glasses between children with intermittent exotropia and those with simple myopia (without intermittent exotropia)? Do DIMS and DOT glasses differ in their myopia control efficacy among children with intermittent exotropia? Does wearing DIMS or DOT glasses affect the binocular visual function of children with intermittent exotropia?
Read the detailed description
Intermittent exotropia (IXT) is a common ophthalmic disorder. It is clinically characterized by outward deviation of the eye position when patients fixate on distant targets, feel fatigued, or become inattentive. This condition impairs stereoscopic vision and visual quality, and may further deteriorate binocular fusion function, thereby considerably interfering with daily activities. Epidemiological data indicate that the prevalence of intermittent exotropia is approximately 4.7% in Asian populations. In China, it accounts for 75.64% of all strabismus cases, ranking first among all types of strabismus. Notably, more than 50% of children with intermittent exotropia are affected by myopia. Several studies suggest that these two conditions may share common pathogenetic mechanisms and present as comorbid disorders.
Currently, the mainstream designs of myopia control glasses are based on two core principles: peripheral defocus control and diffusion optics technology. Peripheral defocus glasses induce myopic defocus by refracting peripheral light to focus in front of or on the retina, which inhibits excessive axial elongation. Lenses adopting diffusion optics technology reduce the contrast of peripheral retinal images via microstructural design, so as to slow myopia progression. A number of clinical trials have verified the favorable efficacy of both lens types for myopia control in general children.
Nevertheless, systematic controlled studies comparing the myopia control effects between the two types of glasses in myopic children with concomitant intermittent exotropia remain scarce. Therefore, this comparative study focusing on this specific population possesses important clinical value and can also provide theoretical evidence for the formulation of individualized myopia management strategies.
- Conditions
- Intermittent Exotropia, Myopia
- Being tested
- DIMS glasses, DOT glasses
- Keywords
- Intermittent exotropia, Myopia control, DIMS, DOT
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIMS glassesDevice
Myopia control glasses with peripheral defocus control design.
DOT glassesDevice
Myopia control glasses with diffusion optics technology.
| Study group | Role | What they receive |
|---|---|---|
| IXT with DIMS | Active comparator | Not described Receives: Device: DIMS glasses |
| IXT with DOT | Active comparator | Not described Receives: Device: DOT glasses |
| Myopia with DIMS | Other | Not described Receives: Device: DIMS glasses |
| Myopia with DOT | Other | Not described Receives: Device: DOT glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Measurement Tool: IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany), a high-resolution swept-source optical coherence tomography (SS-OCT) device for biometric measurement of the eye Measurement Type: Continuous parameters of ocular biometry, mainly including axial length, anterior chamber depth, lens thickness, vitreous depth and other axial dimensional parameters of the eye
Unit of Measure:
Ocular axial length (AL): Millimeters (mm) Anterior chamber depth (ACD): Millimeters (mm) Lens thickness (LT): Millimeters (mm) Vitreous chamber depth (VCD): Millimeters (mm)
Measured: From enrollment to the end of follow-up at 1 year
Refractive error with cycloplegia
Equipment: Cyclopentolate 1%, trial frame, standard trial lens set and logarithmic visual acuity chart for clinical refractive examination Test condition: Completed cycloplegia with cyclopentolate (C) before examination Procedure: The child wears appropriate refractive correction as required. Conduct subjective refraction step by step to determine spherical power, cylindrical power and astigmatic axis. Adjust lenses continuously until the child achieves the clearest and most comfortable vision, then record all refractive parameters and best corrected visual acuity.
Measured: From enrollment to the end of follow-up at 1 year
Secondary outcomes (3)
Stereoacuity
Distant stereoacuity:
Equipment: Random Dots Distant Test (P/N 1006, Vision Assessment Corporation, Illinois, USA) Test distance: 3 meters Range: 63 to 400 arcseconds (log stereoacuity: 1.8 to 2.6 log arcsec) Procedure: The subject identifies stereoscopic shapes at 3 meters. If unable to identify shapes at the 400 arcsec level, record as "nil stereo" (log stereoacuity value: 3.2 log arcsec).
Near stereoacuity:
Equipment: Randot Preschool Stereoacuity test (Stereo Optical Co., Inc, Illinois, USA) Test distance: 40 cm Test disparities: 800, 400, 200, 100, 60, and 40 arcseconds Procedure: The subject identifies shapes at 40 cm. Record the smallest disparity at which the subject correctly identifies at least two of the three shapes. If unable to identify the largest disparity (800 arcsec), record as "nil stereo" (log stereoacuity value: 3.2 log arcsec).
Measured: From enrollment to the end of follow-up at 1 year
Newcastle Control Score (NCS) score
Newcastle Control Score (NCS) score incorporates both objective and subjective measures of control into a simple grading system that differentiates and quantifies the various levels of severity in intermittent distance exotropia.
Minimum and maximum values: Minimum 0, maximum 9. Interpretation of higher scores: Higher scores indicate worse control (i.e., worse outcome). A score of 0 represents perfect control, while a score of 9 represents the poorest control (constant exotropia or severe loss of control).
Measured: From enrollment to the end of follow-up at 1 year
Strabismic deviation
Strabismic deviation is measured by using the prism and alternate cover test (PACT) with accommodative targets at distance (6 m) and near (33 cm), measured after 1 hour of monocular occlusion using prisms, where the endpoint is defined as no eye movement during alternate cover testing.
Measured: From enrollment to the end of follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642934
- Sponsor's protocol ID
- 2025-1537
- Status last verified
- Dec 2025
- First submitted
- 31 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical and privacy restrictions: When the study protocol was approved by the ethics committee, the informed consent form did not include provisions for sharing data with third-party researchers, and participants were not asked for their consent regarding data sharing. Institutional policy and data protection: According to the data management policy of the participating institution, research data are considered internal assets. To protect participant privacy, the data are not permitted to be shared publicly on external platforms or provided to researchers outside the primary research group. Data sensitivity: Even with de-identification, given that the study involves a rare disease or a small sample size (or other specific reasons), there remains a potential risk of re-identification. Therefore, the decision has been made not to share the raw individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Efficacy of Myopia Control Lenses With Different Mechanisms on Controlling Myopia Progression in Patients With Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT07642934
- Acronym / sponsor ID
- 2025-1537
- Conditions
- Intermittent Exotropia, Myopia
- Keywords
- Intermittent exotropia, Myopia control, DIMS, DOT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 11 Jun 2026 (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.
The goal of this clinical trial is to compare the efficacy of myopia control lenses with different working principles in patients with intermittent exotropia aged 6 to 12 years. The main questions it aims to answer are:
Are there any differences in the clinical outcomes of DIMS and DOT glasses between children with intermittent exotropia and those with simple myopia (without intermittent exotropia)? Do DIMS and DOT glasses differ in their myopia control efficacy among children with intermittent exotropia? Does wearing DIMS or DOT glasses affect the binocular visual function of children with intermittent exotropia?
Detailed description
Intermittent exotropia (IXT) is a common ophthalmic disorder. It is clinically characterized by outward deviation of the eye position when patients fixate on distant targets, feel fatigued, or become inattentive. This condition impairs stereoscopic vision and visual quality, and may further deteriorate binocular fusion function, thereby considerably interfering with daily activities. Epidemiological data indicate that the prevalence of intermittent exotropia is approximately 4.7% in Asian populations. In China, it accounts for 75.64% of all strabismus cases, ranking first among all types of strabismus. Notably, more than 50% of children with intermittent exotropia are affected by myopia. Several studies suggest that these two conditions may share common pathogenetic mechanisms and present as comorbid disorders.
Currently, the mainstream designs of myopia control glasses are based on two core principles: peripheral defocus control and diffusion optics technology. Peripheral defocus glasses induce myopic defocus by refracting peripheral light to focus in front of or on the retina, which inhibits excessive axial elongation. Lenses adopting diffusion optics technology reduce the contrast of peripheral retinal images via microstructural design, so as to slow myopia progression. A number of clinical trials have verified the favorable efficacy of both lens types for myopia control in general children.
Nevertheless, systematic controlled studies comparing the myopia control effects between the two types of glasses in myopic children with concomitant intermittent exotropia remain scarce. Therefore, this comparative study focusing on this specific population possesses important clinical value and can also provide theoretical evidence for the formulation of individualized myopia management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IXT with DIMS | Active comparator | Device: DIMS glasses |
| IXT with DOT | Active comparator | Device: DOT glasses |
| Myopia with DIMS | Other | Device: DIMS glasses |
| Myopia with DOT | Other | Device: DOT glasses |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Participants aged 6 to 12 years (6 ≤ age ≤ 12 years). Written informed consent from legal guardians is mandatory.
- Patients with basic-type intermittent exotropia (IXT) meeting all the following criteria:
- Based on cycloplegic spherical equivalent (SE), the myopic refractive error of both eyes ranges from -6.0 D to -0.5 D.
- The logMAR value of monocular distance best-corrected visual acuity (BCVA) measured by the ETDRS chart is ≤ 0.2, and no amblyopia is present.
- Parents and children are willing to participate in this clinical trial and can complete the entire study protocol.
Key exclusion criteria (6 listed)
- Participants who have worn myopia control glasses or received other myopia interventions, including low-concentration atropine and phototherapy instruments, within the past 6 months (excluding DIMS and DOT glasses).
- Those with severe systemic diseases or cognitive impairment that hinders follow-up attendance and clinical examinations.
- 4. Subjects with astigmatism of ≥ 2 diopters (D) in either eye after cycloplegia; individuals enrolled in other interventional trials.
- 5. Patients with active ocular inflammation in either eye. 6. Those diagnosed with ocular diseases or presenting with clinically significant abnormalities on ophthalmic examinations.
- 7. Participants are currently receiving visual function training or other clinical interventions for intermittent exotropia.
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 |
|---|---|---|
| DIMS glassesMyopia control glasses with peripheral defocus control design. | Device | IXT with DIMS, Myopia with DIMS |
| DOT glassesMyopia control glasses with diffusion optics technology. | Device | IXT with DOT, Myopia with DOT |
Primary outcome
Axial length
Time frame: From enrollment to the end of follow-up at 1 year
Measurement Tool: IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany), a high-resolution swept-source optical coherence tomography (SS-OCT) device for biometric measurement of the eye Measurement Type: Continuous parameters of ocular biometry, mainly including axial length, anterior chamber depth, lens thickness, vitreous depth and other axial dimensional parameters of the eye Unit of Measure: Ocular axial length (AL): Millimeters (mm) Anterior chamber depth (ACD): Millimeters (mm) Lens thickness (LT): Millimeters (mm) Vitreous chamber depth (VCD): Millimeters (mm)
Refractive error with cycloplegia
Time frame: From enrollment to the end of follow-up at 1 year
Equipment: Cyclopentolate 1%, trial frame, standard trial lens set and logarithmic visual acuity chart for clinical refractive examination Test condition: Completed cycloplegia with cyclopentolate (C) before examination Procedure: The child wears appropriate refractive correction as required. Conduct subjective refraction step by step to determine spherical power, cylindrical power and astigmatic axis. Adjust lenses continuously until the child achieves the clearest and most comfortable vision, then record all refractive parameters and best corrected visual acuity.
3 secondary outcomes
Stereoacuity
Time frame: From enrollment to the end of follow-up at 1 year
Newcastle Control Score (NCS) score
Time frame: From enrollment to the end of follow-up at 1 year
Strabismic deviation
Time frame: From enrollment to the end of follow-up at 1 year
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 11 Jun 2026.
- Individual participant dataSharing planned: No. Ethical and privacy restrictions: When the study protocol was approved by the ethics committee, the informed consent form did not include provisions for sharing data with third-party researchers, and participants were not asked for their consent regarding data sharing. Institutional policy and data protection: According to the data management policy of the participating institution, research data are considered internal assets. To protect participant privacy, the data are not permitted to be shared publicly on external platforms or provided to researchers outside the primary research group. Data sensitivity: Even with de-identification, given that the study involves a rare disease or a small sample size (or other specific reasons), there remains a potential risk of re-identification. Therefore, the decision has been made not to share the raw individual participant data.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing DIMS glasses and DOT glasses in people with Intermittent Exotropia and Myopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Xiaoning Yu, M.D. (+86 13738170635, yxnzju@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: From enrollment to the end of follow-up at 1 year). 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 11 Jun 2026.