Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital Cataract

Keywords

Photochromic LensesCongenital CataractAxial lengthMyopic 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 LensesDevice

Standard conventional bifocal spectacles without peripheral defocus design.

Active Comparator: Conventional Bifocal Lenses

Individually Customized Bifocal + Defocus LensesDevice

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

Experimental: Individually Customized Bifocal + Defocus Lenses

Eligibility Criteria

Age4 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

Eye & ENT Hospital of Fudan University
Otherlead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Jin Yang, PhDCONTACT13671632525 jin_er76@hotmail.com

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

Actual (reported)

Primary Completion

August 6, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Guangke Lenses in Congenital Cataract

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Active Comparator: Conventional Bifocal Lenses

Experimental: Individually Customized Bifocal + Defocus Lenses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Active Comparator: Conventional Bifocal Lenses

Experimental: Individually Customized Bifocal + Defocus Lenses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations