Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy
- Conditions
- Congenital Cataract
- Interventions
- Procedure: PCCC+A-Vit procedureProcedure: PCCC procedure without A-vit
- Registration Number
- NCT05136209
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- Intraocular pressure >21 mmHg
- History of ocular trauma and intraocular surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCCC+A-Vit procedure PCCC+A-Vit procedure Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit PCCC procedure without A-vit PCCC procedure without A-vit Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method CCT change 5 years Change from baseline in the central corneal thickness (CCT) measured by pentacam.
AL change 5 years Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
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)
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China