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Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts

NCT02581046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-10-20

No results posted yet for this study

Summary

Congenital cataract is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and rigorous postoperative supervision for adverse complication. In this trial, we aimed to compare the difference of postoperative outcome between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month, 18month and 24month postoperatively.

Conditions

  • Cataract

Interventions

PROCEDURE

Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients

The surgical timing of phacoemulsification is perform at the age of 3 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.

PROCEDURE

Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients

The surgical timing of phacoemulsification is perform at the age of 6 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.

DRUG

Subconjunctival dexamethasone and general anesthesia

All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Sponsors & Collaborators

  • Ministry of Health, China

    collaborator OTHER_GOV

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Haotian Lin, M.D., Ph.D · Zhongshan Ophthalmic Center, Sun Yat-sen University

  • Yizhi Liu, M.D., Ph.D · Zhongshan Ophthalmic Center, Sun Yat-sen University

  • Weirong Chen, M.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581046 on ClinicalTrials.gov