Congenital CataractNCT07778797
Guangke Lenses in Congenital Cataract
A study testing Conventional Bifocal Lenses and Individually Customized Bifocal + Defocus Lenses in people with Congenital Cataract, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- Conventional Bifocal Lenses and Individually Customized Bifocal + Defocus Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to 6 Aug 2030
- Phase
- Interventional
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Jin Yang, PhD, 13671632525, jin_er76@hotmail.com
About this study
Official title: Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Read the detailed description
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.
- Conditions
- Congenital Cataract
- Being tested
- Conventional Bifocal Lenses, Individually Customized Bifocal + Defocus Lenses
- Keywords
- Photochromic Lenses, Congenital Cataract, Axial length, Myopic shift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Bifocal LensesDevice
Standard conventional bifocal spectacles without peripheral defocus design.
Individually Customized Bifocal + Defocus LensesDevice
Individually customized bifocal spectacles with peripheral defocus design for myopia control.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Conventional Bifocal Lenses | Active comparator | Participants in this arm will wear conventional bifocal spectacles (without defocus design). Receives: 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. Receives: Device: Individually Customized Bifocal + Defocus Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Axial Length (AL)
Change in axial length (in millimeters) from baseline measured by optical biometry.
Measured: Baseline to 12 months
Change in Spherical Equivalent Refraction (SER)
Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
Measured: Baseline to 12 months
Secondary outcomes (3)
Change in Corneal Curvature
Change in corneal curvature (in millimeters) measured by corneal topography.
Measured: Baseline to 12 months
Change in Intraocular Pressure (IOP)
Change in IOP (in mmHg) measured by non-contact tonometry.
Measured: Baseline to 12 months
Incidence of Adverse Events
Number of participants with ocular or systemic adverse events related to the study lenses.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start6 Aug 2025
- Primary completion6 Aug 2028 (estimated)
- Study completion6 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yang, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778797
- Sponsor's protocol ID
- Guangke lenses_2025
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No