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

October 18, 2015 updated by: Haotian Lin, Sun Yat-sen University

Effect of the Timing of Lens-removal Cataract Surgery on Postoperative Complications Rate Among Patients With Bilateral Congenital Cataracts

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Congenital cataract is a priority of Vision 2020: the Right to Sight, the global initiative to reduce the world's burden of avoidable blindness, because it 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 postoperative supervision for adverse complication is also essential. The timing of surgery of childhood cataract depends on the etiology and on the degree of visual interference. Severe bilateral cataracts with significant obstruction of the visual axis must be treated and surgery is recommended as soon as possible after discovery.

Several previous studies claimed that ideally cataracts should be removed before 3 months of age, while the result of recent researches shows that too early intervention for cataract surgery seems aggressive and would cause serious complications, which might cause poor long-term visual outcomes. Therefore, in order to control childhood blindness and severe visual impairment in China, it is of great importance to ensure that pediatric patients with cataract could have good timing of surgery, postoperative rigorous supervision, accurate optical rehabilitation and comprehensive treatment of amblyopia.

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 months, 6 months, 9 months, 12 months, 18months and 24months after cataract surgery.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children diagnosis with bilateral congenital cataract for entire lens without other ocular abnormality
  • No more than 3 month old
  • Have signed a consent form
  • Can be followed

Exclusion Criteria:

  • Children not identified with congenital cataract
  • Have not signed consent form
  • Be not able to be followed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.
Drug: Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
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.
Experimental: 6 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..
Drug: Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)
Time Frame: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)
Time Frame: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)
Time Frame: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma
Time Frame: 2 year after surgery
2 year after surgery
Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification（PCO）
Time Frame: 2 year after surgery
2 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Ministry of Health, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 18, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 18, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2010-China7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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