Congenital CataractNCT04323982
Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining
A study testing new surgical procedure and traditional surgical procedure in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior… Read more about this study
- Who is it for?
- Ages 3 months to 13 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- new surgical procedure and traditional surgical 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
- 27 Mar 2020to 25 Mar 2021
- 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 3 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3 months and 13 years
- Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
- Informed consent signed by a parent or legal guardian
Who cannot join
- Intraocular pressure >21 mmHg
- Preterm birth (<28 weeks)
- Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
- History of ocular trauma
- Previous intraocular surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Qiwei Wang, M.D., Ph.D, + 86-13924025677, wang_qiwei@126.com
About this study
Official title: Comparison of Traditional Cataract Surgery and Traditional Surgery Combine Triamcinolone Staining of the Anterior Vitreous in Treating Congenital Cataracts
Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.
Read the detailed description
Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery.
In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups
- Conditions
- Congenital Cataract
- Being tested
- new surgical procedure, traditional surgical procedure
- Keywords
- congenital cataract, Triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new surgical procedureProcedure or surgery
（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）
traditional surgical procedureProcedure or surgery
（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）
| Study group | Role | What they receive |
|---|---|---|
| New Cataract Surgery | Experimental | Traditional surgery combined triamcinolone staining of the anterior vitreous (TA) Receives: Procedure: new surgical procedure |
| Traditional Cataract Surgery | Active comparator | For patients younger than 2 years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + A-vit) For patients older than 2years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + primary intraocular lens implantation + anterior vitrectomy (ACCC+ I/A + PCCC + IOL + A-vit) Receives: Procedure: traditional surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of high intraocular pressure
Determined with the Tono-pen.
Measured: 5 years
incidence of visual axis opacification
Visual axis obscuration will be evaluated based on the retroillumination.
Measured: 5 years
incidence of uveitis and iris/pupil abnormality
Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.
Measured: 5 years
Secondary outcomes (3)
Best corrected visual acuity
Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
Measured: 5 years
Central corneal thickness
Determined with the pentacam.
Measured: 5 years
Central macular thickness
Determined with the optical coherence tomography.
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 posted27 Mar 2020
- Study start27 Mar 2020
- Primary completion25 Mar 2021 (estimated)
- Study completion25 Mar 2021 (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
- Participant
- 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
- Chen Weirong, MD, Study chair, SunYat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323982
- Sponsor's protocol ID
- CCPMOH2020-China-1
- Status last verified
- Jun 2020
- First submitted
- 25 Mar 2020
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Traditional Cataract Surgery and Traditional Surgery Combine Triamcinolone Staining of the Anterior Vitreous in Treating Congenital Cataracts
- ClinicalTrials.gov ID
- NCT04323982
- Acronym / sponsor ID
- CCPMOH2020-China-1
- Conditions
- Congenital Cataract
- Keywords
- congenital cataract, Triamcinolone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 25 Mar 2021 (estimated)
- Study completion
- 25 Mar 2021 (estimated)
- First posted
- 27 Mar 2020 (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.
Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.
Detailed description
Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery.
In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Cataract Surgery | Experimental | Procedure: new surgical procedureTraditional surgery combined triamcinolone staining of the anterior vitreous (TA) |
| Traditional Cataract Surgery | Active comparator | Procedure: traditional surgical procedureFor patients younger than 2 years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + A-vit) For patients older than 2years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + primary intraocular lens implantation + anterior vitrectomy (ACCC+ I/A + PCCC + IOL + A-vit) |
Who may qualify
- Ages
- 3 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 3 months and 13 years
- Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
- Informed consent signed by a parent or legal guardian
Key exclusion criteria (5 listed)
- Intraocular pressure >21 mmHg
- Preterm birth (<28 weeks)
- Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
- History of ocular trauma
- Previous 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 |
|---|---|---|
| new surgical procedure（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit） | Procedure or surgery | New Cataract Surgery |
| traditional surgical procedure（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit） | Procedure or surgery | Traditional Cataract Surgery |
Primary outcome
incidence of high intraocular pressure
Time frame: 5 years
Determined with the Tono-pen.
incidence of visual axis opacification
Time frame: 5 years
Visual axis obscuration will be evaluated based on the retroillumination.
incidence of uveitis and iris/pupil abnormality
Time frame: 5 years
Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.
3 secondary outcomes
Best corrected visual acuity
Time frame: 5 years
Central corneal thickness
Time frame: 5 years
Central macular thickness
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 4 Jun 2020.
- Homepage of Zhongshan Ophthalmic CenterLink provided by the sponsor.
- 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.
Chen Weirong, MD study chair
SunYat-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 new surgical procedure and traditional surgical 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 3 inclusion and 5 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 4 Jun 2020. 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 Wang Qiwei, MD (+86-13924025677, wang_qiwei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of high intraocular pressure (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 4 Jun 2020.