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Recruiting

NCT Number: NCT07778797

Guangke Lenses in Congenital Cataract

This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.

Recruiting

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Key information

Conditions

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Jin Yang, PhD

CONTACT

[email protected]

13671632525

About this study

Children with congenital cataract who have undergone surgery will be fitted with individually customized bifocal + defocus spectacles. Refraction and axial length will be monitored at regular intervals to assess the effect of the intervention on myopic progression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 4 to 12 years (inclusive) at the time of enrollment. Diagnosed with bilateral congenital cataracts. Has undergone bilateral cataract extraction with intraocular lens (IOL) implantation.

Time since cataract surgery is between 1 to 6 months (inclusive) at the time of enrollment.

Able to undergo regular ophthalmic examinations (including refraction, axial length measurement, and intraocular pressure assessment).

Parent(s) or legal guardian(s) are willing and able to provide written informed consent.

Exclusion criteria

Presence of any systemic disease (e.g., metabolic disorders, autoimmune diseases, genetic syndromes, etc.).

Presence of any ocular disease other than congenital cataracts (e.g., glaucoma, uveitis, retinal disorders, corneal diseases, strabismus, amblyopia, etc.).

Previous or current use of myopia control treatments, including but not limited to atropine eye drops, orthokeratology (Ortho-K) lenses, or other myopia control spectacle lenses.

History of ocular trauma or intraocular surgery other than cataract extraction and IOL implantation.

Known allergy or hypersensitivity to any materials or components used in the study lenses.

Inability to comply with the study protocol or complete scheduled follow-up visits.

Participation in another interventional clinical trial within the past 30 days.

Treatment and study plan

Conventional Bifocal Lenses

Device

Standard conventional bifocal spectacles without peripheral defocus design.

Individually Customized Bifocal + Defocus Lenses

Device

Individually customized bifocal spectacles with peripheral defocus design for myopia control.

Primary outcomes

  1. Change in Axial Length (AL)

    Time frame: Baseline to 12 months

    Change in axial length (in millimeters) from baseline measured by optical biometry.

  2. Change in Spherical Equivalent Refraction (SER)

    Time frame: Baseline to 12 months

    Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.

Secondary outcomes

  1. Change in Corneal Curvature

    Time frame: Baseline to 12 months

    Change in corneal curvature (in millimeters) measured by corneal topography.

  2. Change in Intraocular Pressure (IOP)

    Time frame: Baseline to 12 months

    Change in IOP (in mmHg) measured by non-contact tonometry.

  3. Incidence of Adverse Events

    Time frame: Baseline to 12 months

    Number of participants with ocular or systemic adverse events related to the study lenses.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Yang, Dr.

CONTACT

[email protected]

021-64377134

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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