Trials / Unknown
UnknownNCT04357249
Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Wenzhou Medical University · Academic / Other
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. The investigators included children with cataract planning to have cataract surgery in our institute. Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. The investigators recorded age at surgery, gender and relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.All patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. Patients were followed for two years or until the development of severe VAO requiring Nd: YAG laser capsulotomy, whichever came first. The examinations consisted of visual acuity, IOP measurement by a Tonopen tonometer (Reichert, Inc., Seefeld, Germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).The primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.A paired T test was used to compare the areas of the PCO between the postoperative visits and baseline.
Conditions
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2020-07-01
- Completion
- 2020-08-01
- First posted
- 2020-04-22
- Last updated
- 2020-04-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04357249. Inclusion in this directory is not an endorsement.