Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy
Primary Purpose
Congenital Cataract
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PCCC procedure without A-vit
PCCC+A-Vit procedure
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Cataract focused on measuring Congenital cataract surgery, anterior vitrectomy, postoperative complications
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
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PCCC procedure without A-vit
PCCC+A-Vit procedure
Arm Description
Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL
Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit
Outcomes
Primary Outcome Measures
Number of participants with visual axis opacification
Number of participants with visual axis opacification evaluated based on the retro-illumination.
Number of participants with uveitis and iris/pupil abnormality
Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.
IOP
Intraocular pressure measured by the Tono-pen or non-contact tonometer
Secondary Outcome Measures
BCVA change
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.
AL change
Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
CCT change
Change from baseline in the central corneal thickness (CCT) measured by pentacam.
CFT change
Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)
Full Information
NCT ID
NCT05136209
First Posted
November 11, 2021
Last Updated
November 25, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05136209
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
Congenital cataract surgery, anterior vitrectomy, postoperative complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCCC procedure without A-vit
Arm Type
Experimental
Arm Description
Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL
Arm Title
PCCC+A-Vit procedure
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit
Intervention Type
Procedure
Intervention Name(s)
PCCC procedure without A-vit
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCCC+A-Vit procedure
Intervention Description
PCCC+A-Vit procedure
Primary Outcome Measure Information:
Title
Number of participants with visual axis opacification
Description
Number of participants with visual axis opacification evaluated based on the retro-illumination.
Time Frame
5 years
Title
Number of participants with uveitis and iris/pupil abnormality
Description
Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.
Time Frame
5 years
Title
IOP
Description
Intraocular pressure measured by the Tono-pen or non-contact tonometer
Time Frame
5 years
Secondary Outcome Measure Information:
Title
BCVA change
Description
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
Title
AL change
Description
Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
Time Frame
5 years
Title
CCT change
Description
Change from baseline in the central corneal thickness (CCT) measured by pentacam.
Time Frame
5 years
Title
CFT change
Description
Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingfeng Qin
Phone
13724104066
Email
qintf3@mail2.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weirong Chen, MD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingfeng Qin
Phone
13724104066
Email
qintf3@mail2.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy
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