Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Location status: Recruiting
NCT Number: NCT05136209
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.
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Request Info1 month–18 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510080, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
PCCC+A-Vit procedure
Time frame: 5 years
Number of participants with visual axis opacification evaluated based on the retro-illumination.
Time frame: 5 years
Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.
Time frame: 5 years
Intraocular pressure measured by the Tono-pen or non-contact tonometer
Time frame: 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.
Time frame: 5 years
Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
Time frame: 5 years
Change from baseline in the central corneal thickness (CCT) measured by pentacam.
Time frame: 5 years
Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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