Clinical trial NCT05136209: Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy
Official title: Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Cataract
Keywords: Congenital cataract surgery
anterior vitrectomy
postoperative complications
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with visual axis opacification
timeFrame: 5 years
measure: Number of participants with uveitis and iris/pupil abnormality
timeFrame: 5 years
measure: IOP
timeFrame: 5 years
Secondary outcomes:
measure: BCVA change
timeFrame: 5 years
measure: AL change
timeFrame: 5 years
measure: CCT change
timeFrame: 5 years
measure: CFT change
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: