Skip to main content
OpenTrials
Completed

NCT Number: NCT02581046

Effect of the Timing of Cataract Surgery on Complications in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

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

Procedure

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.

Subconjunctival dexamethasone and general anesthesia

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma

    Time frame: 2 year after surgery

  2. Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification（PCO）

    Time frame: 2 year after surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Ministry of Health, China

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2015
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.