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Efficacy and safety of defocus incorporated multiple segments spectacles and orthokeratology in children with intermittent exotropia combined with myopia

Efficacy and safety of defocus incorporated multiple segments spectacles and orthokeratology in children with intermittent exotropia combined with myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087705
Enrollment
Unknown
Registered
2024-08-01
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermittent exotropia combined with myopia

Interventions

defocus incorporated multiple segments spectacles: defocus incorporated multiple segments spectacles
sing vision lenslets:sing vision lenslets

Sponsors

Sanmenxia Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Age 8 to 15 years old (including 8 and 15 years old), gender is not limited; 2. post-ciliary muscle paralysis optometry with equivalent spherical lenses between -6.00 D and -0.50 D in both eyes, with astigmatism and refractive parametrization less than or equal to 1.50 D; 3. confirmed diagnosis of intermittent exotropia, with a hyperopic exotropia of 10? to 30? as measured by the trigonometric alternating masking test after masking the nondominant eye for 30 minutes; previous corrective surgery for strabismus and residual exotropia with a hyperopic exotropia of 10? to 30?; 4. In-office control scores of 1 to 3 for both hyperopia and hyperopia (measured 3 times by the same examiner within 30 minutes, with at least 2 scores meeting the requirements); 5. Best-corrected distance visual acuity of =0.8 in both eyes with a difference of <2 lines; 6. be able to cooperate in the continuous wearing of eyeglasses during waking hours; 7. patients and their guardians understand the content of the program and are able to attend regular follow-up appointments.

Exclusion criteria

Exclusion criteria: 1. Received any method of myopia control within the past 6 months: including 0.01% atropine drops, feeder lenses, keratoconus, and out-of-focus glasses; 2. Diagnosed with eye disease or clinically significant abnormalities on eye examination; 3. serious health problems or cognitive impairment affecting follow-up or inability to cooperate with the examination; 4. Any other circumstances in which the investigator believes that the patient should not participate in this trial for safety reasons or in the interest of the patient.

Design outcomes

Primary

MeasureTime frame
Axial length;Spherical equivalent;In-office control scores ;

Secondary

MeasureTime frame
Stereopsis;Accommodative amplitude ;Accommodative convergence / accommodation ratio (AC/A);Strabismus degree (distance);Strabismus degree (near);

Countries

China

Contacts

Public ContactLi Xuejiao; Dang Yalong

Sanmenxia Central Hospital

yalong.dang@gmail.com+86 135 6961 0688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026