Congenital CataractNCT05136209
Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy
A study testing PCCC procedure without A-vit and PCCC+A-Vit procedure in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- PCCC procedure without A-vit and PCCC+A-Vit procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Intraocular pressure >21 mmHg
- History of ocular trauma and intraocular surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Tingfeng Qin, 13724104066, qintf3@mail2.sysu.edu.cn
About this study
Official title: Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery
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.
Read the 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.
- Conditions
- Congenital Cataract
- Being tested
- PCCC procedure without A-vit, PCCC+A-Vit procedure
- Keywords
- Congenital cataract surgery, anterior vitrectomy, postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCCC procedure without A-vitProcedure or surgery
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 procedureProcedure or surgery
PCCC+A-Vit procedure
| Study group | Role | What they receive |
|---|---|---|
| PCCC procedure without A-vit | Experimental | Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL Receives: Procedure: PCCC procedure without A-vit |
| PCCC+A-Vit procedure | Active comparator | Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit Receives: Procedure: PCCC+A-Vit procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with visual axis opacification
Number of participants with visual axis opacification evaluated based on the retro-illumination.
Measured: 5 years
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.
Measured: 5 years
IOP
Intraocular pressure measured by the Tono-pen or non-contact tonometer
Measured: 5 years
Secondary outcomes (4)
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.
Measured: 5 years
AL change
Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
Measured: 5 years
CCT change
Change from baseline in the central corneal thickness (CCT) measured by pentacam.
Measured: 5 years
CFT change
Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Weirong Chen, MD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136209
- Sponsor's protocol ID
- CCPMOH2021-China12
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT05136209
- Acronym / sponsor ID
- CCPMOH2021-China12
- Conditions
- Congenital Cataract
- Keywords
- Congenital cataract surgery, anterior vitrectomy, postoperative complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCCC procedure without A-vit | Experimental | Procedure: PCCC procedure without A-vitProcedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL |
| PCCC+A-Vit procedure | Active comparator | Procedure: PCCC+A-Vit procedureProcedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Intraocular pressure >21 mmHg
- History of ocular trauma and intraocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCCC procedure without A-vitIn 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. | Procedure or surgery | PCCC procedure without A-vit |
| PCCC+A-Vit procedurePCCC+A-Vit procedure | Procedure or surgery | PCCC+A-Vit procedure |
Primary outcome
Number of participants with visual axis opacification
Time frame: 5 years
Number of participants with visual axis opacification evaluated based on the retro-illumination.
Number of participants with uveitis and iris/pupil abnormality
Time frame: 5 years
Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.
IOP
Time frame: 5 years
Intraocular pressure measured by the Tono-pen or non-contact tonometer
4 secondary outcomes
BCVA change
Time frame: 5 years
AL change
Time frame: 5 years
CCT change
Time frame: 5 years
CFT change
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weirong Chen, MD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCCC procedure without A-vit and PCCC+A-Vit procedure in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingfeng Qin (13724104066, qintf3@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with visual axis opacification (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.