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

Sun Yat-sen University

Status: Completed

Conditions: Cataract

Treatments: Procedure: Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients; Drug: Subconjunctival dexamethasone and general anesthesia; Procedure: Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02581046

CCPMOH2010-China7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

3 month surgical group

Experimental group

Description:

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.

Treatment:

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

Drug: Subconjunctival dexamethasone and general anesthesia

6 month surgical group

Experimental group

Description:

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..

Treatment:

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

Drug: Subconjunctival dexamethasone and general anesthesia