Congenital Cataract
Conditions
Keywords
congenital cataract, Triamcinolone
Brief summary
Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.
Detailed description
Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery. In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups
Interventions
PROCEDUREnew surgical procedure
（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）
PROCEDUREtraditional surgical procedure
（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Months to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 3 months and 13 years 2. Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity) 3. Informed consent signed by a parent or legal guardian
Exclusion criteria
1. Intraocular pressure \>21 mmHg 2. Preterm birth (\<28 weeks) 3. Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy) 4. History of ocular trauma 5. Previous intraocular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of high intraocular pressure | 5 years | Determined with the Tono-pen. |
| incidence of visual axis opacification | 5 years | Visual axis obscuration will be evaluated based on the retroillumination. |
| incidence of uveitis and iris/pupil abnormality | 5 years | Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 5 years | Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age. |
| Central corneal thickness | 5 years | Determined with the pentacam. |
| Central macular thickness | 5 years | Determined with the optical coherence tomography. |
Countries
China
Contacts
Primary ContactWang Qiwei, MD
Outcome results
None listed