Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts
| Registry | NCT03240796 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Sun Yat-sen University (Other) |
| Conditions | Congenital Cataract |
| Interventions | minimal invasive surgery and secondary IOL implantation, traditional cataract surgery and secondary IOL implantation (Procedure) |
| Dates | start 2017-08-01, primary completion 2019-12-01 (estimated), completion 2019-12-01 (estimated), first posted 2017-08-07, last updated 2019-04-10 |
| Locations | 1 site in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| minimal invasive surgery and secondary IOL implantation | Experimental | Procedure: minimal invasive surgery and secondary IOL implantation | |
| traditional cataract surgery and secondary IOL implantation | Active comparator | Procedure: traditional cataract surgery and secondary IOL implantation |
Sex: All, ages: 24 Months to 72 Months
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
| Facility | City | Country | Status |
|---|---|---|---|
| Zhongshan Ophthalmic Center,Sun Yat-sen U | Guangzhou, Guangdong | China | Recruiting |