Secondary Intraocular Lens Implantation in Pediatric Patients

Not Applicable

• Conditions: Congenital Cataract
• Interventions: Procedure: minimal invasive surgery and secondary IOL implantation; Procedure: traditional cataract surgery and secondary IOL implantation

• Registration Number: NCT03240796
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation.

Detailed Description

Pediatric patients received minimal invasive surgery and traditional lens removal surgery (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy of primary surgery: Group I: the participants received minimal invasive surgery, while in Group II, the participants received a traditional cataract surgery. Investigators perform a secondary intraocular lens implantation for the patients. Investigators compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups after the first and the second surgery, aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Study Timeline

• Study First Submitted: 2017-07-26
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian

Exclusion Criteria

• Intraocular pressure >21 mmHg at enrollment Preterm birth (<28 weeks) Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy) History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family History of ocular trauma Microcornea Persistent hyperplastic primary vitreous Rubella Lowe syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
minimal invasive surgery and secondary IOL implantation	minimal invasive surgery and secondary IOL implantation	-
traditional cataract surgery and secondary IOL implantation	traditional cataract surgery and secondary IOL implantation	-

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)	measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.

Secondary Outcome Measures

Name	Time	Method
Visual axis opacification	recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)	Visual axis opacification was recorded by standardized slit lamp retroillumination.
High intraocular pressure	recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)	measured with Tono-pen tonometer
Bi-ocular visual function	The examination is performed when the patient is four years old and older, once a year.	determined with synoptophore

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U; 🇨🇳 Guangzhou, Guangdong, China