Congenital Cataract
Conditions
Keywords
Congenital cataract surgery, anterior vitrectomy, postoperative complications
Brief summary
Selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. This prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (PCCC) with or without anterior vitrectomy (A-Vit) in treating congenital cataracts.
Detailed description
Due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. The major concerned postoperative problem is the after-cataract formation. As a result, PCCC with A-Vit is usually performed to prevent the formation of secondary cataracts. However. Debate over the indication and surgical procedure still persists since A-Vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. Thus, it is necessary to evaluate the safety and effectiveness of PCCC without A-Vit in congenital cataract surgery. In this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit. PCCC+A-Vit procedure includes anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), PCCC, and A-Vit. Primary intraocular lens implantation (IOL) is performed in children older than age of two. Investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure between two groups.
Interventions
PROCEDUREPCCC procedure without A-vit
In this randomized clinical trial, patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit.
PROCEDUREPCCC+A-Vit procedure
PCCC+A-Vit procedure
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children with bilateral congenital cataracts without other ocular abnormalities * Gestational age at birth \>37 weeks * No more than 18 years old * Pupils could dilate normally pre-operation * Have signed a consent form * Can be followed
Exclusion criteria
* Intraocular pressure \>21 mmHg * History of ocular trauma and intraocular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with visual axis opacification | 5 years | Number of participants with visual axis opacification evaluated based on the retro-illumination. |
| Number of participants with uveitis and iris/pupil abnormality | 5 years | Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination. |
| IOP | 5 years | Intraocular pressure measured by the Tono-pen or non-contact tonometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA change | 5 years | Change from baseline in the best corrected visual acuity (BCVA) measured by the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age. |
| CFT change | 5 years | Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT) |
| AL change | 5 years | Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan |
| CCT change | 5 years | Change from baseline in the central corneal thickness (CCT) measured by pentacam. |
Countries
China
Contacts
Primary ContactTingfeng Qin
Outcome results
None listed