Secondary Intraocular Lens Implantation in Pediatric Patients

Sun Yat-sen University

Status: Unknown

Conditions: Congenital Cataract

Treatments: Procedure: traditional cataract surgery and secondary IOL implantation; Procedure: minimal invasive surgery and secondary IOL implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03240796

CCPMOH2017-China-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 24 to 72 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

minimal invasive surgery and secondary IOL implantation

Experimental group

Treatment:

Procedure: minimal invasive surgery and secondary IOL implantation

traditional cataract surgery and secondary IOL implantation

Active Comparator group

Treatment:

Procedure: traditional cataract surgery and secondary IOL implantation