CompletedNot Applicable

Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery

China60 participantsStarted 2017-03-01

Plain-language summary

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the retinal nerve fiber layer. However, there are different opinions about the effect of amblyopia on the optic nerve fiber thickness around the optic disc at home and abroad. Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before and after surgery. Investigators dynamically observed changes in RNFL and CMT to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

Who can participate

Age range

1 Month – 12 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * congenital cataract Exclusion Criteria: * incooperative to complete the preoperative and postoperative examinations

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RNFLT

Timeframe: 1 year

CMT

Timeframe: 1 year

Trial details

NCT IDNCT03621579

SponsorWenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-01

View on ClinicalTrials.gov More Congenital Cataract trials