Guangke Lenses in Congenital Cataract

NCT07778797 | Recruiting

• 1 other identifier: Guangke lenses_2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Cataract

Keywords

Photochromic Lenses; Congenital Cataract; Axial length; Myopic shift

Outcome Measures

Primary Outcomes (2)

• Change in Axial Length (AL)

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

  Baseline to 12 months

• Change in Spherical Equivalent Refraction (SER)

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

  Baseline to 12 months

Secondary Outcomes (3)

• Change in Corneal Curvature

  Baseline to 12 months

• Change in Intraocular Pressure (IOP)

  Baseline to 12 months

• Incidence of Adverse Events

  Baseline to 12 months

Study Arms (2)

Active Comparator: Conventional Bifocal Lenses

ACTIVE COMPARATOR

Participants in this arm will wear conventional bifocal spectacles (without defocus design).

Device: Conventional Bifocal Lenses

Experimental: Individually Customized Bifocal + Defocus Lenses

EXPERIMENTAL

Participants in this arm will wear individually customized bifocal spectacles with peripheral defocus design.

Device: Individually Customized Bifocal + Defocus Lenses

Interventions

Conventional Bifocal Lenses DEVICE

Standard conventional bifocal spectacles without peripheral defocus design.

Active Comparator: Conventional Bifocal Lenses

Individually Customized Bifocal + Defocus Lenses DEVICE

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

Experimental: Individually Customized Bifocal + Defocus Lenses

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Central Study Contacts

Jin Yang, Dr.

CONTACT

021-64377134; jin_er76@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: August 6, 2025
• Primary Completion (Estimated): August 6, 2028
• Study Completion (Estimated): August 6, 2030
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

CN (1)