Congenital CataractNCT03230799
Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
A study testing minimal invasive lens surgery and traditional cataract surgery in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Previously, we have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital… Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- minimal invasive lens surgery and traditional cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2017to Dec 2022
- 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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 month and 24 months
- Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
- Informed consent signed by a parent or legal guardian
Who cannot join
- confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract
- Intraocular pressure >21 mmHg
- Preterm birth (<28 weeks)
- Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
- History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
- History of ocular trauma
Show all 10Show fewer
- Microcornea
- Persistent hyperplastic primary vitreous
- Rubella
- Lowe syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center,Sun Yat-sen U
Guangzhou, Guangdong, 510060
Haotian Lin, Phd, +86-20-87330475, gddlht@gmail.com
Haotian Lin, PhD
About this study
Official title: Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Previously, we have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.
Read the detailed description
Patients with congenital cataract that requires surgical intervention are enrolled. Then the patients are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.
- Conditions
- Congenital Cataract
- Being tested
- minimal invasive lens surgery, traditional cataract surgery
- Keywords
- congenital cataract, minimal invasive surgery, secondary intraocular lens implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal invasive lens surgeryProcedure or surgery
We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities.
traditional cataract surgeryProcedure or surgery
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| traditional cataract surgery | Active comparator | Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit) Receives: Procedure: traditional cataract surgery |
| minimal invasive lens surgery | Experimental | Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration Receives: Procedure: minimal invasive lens surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best correctied 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: recorded at each follow-up to five years of age.
Secondary outcomes (3)
High intra-ocular pressure
Determined with Tono-Pen tonometer at each follow-up
Measured: after lens removal to five years of age.
Visual axis opacification
Determined with slit-lamp photography at each follow-up
Measured: after lens removal to five years of age.
Bi-ocular visual function
Determined with synoptophore
Measured: performed when the patient is four years old and five years old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start28 Jul 2017
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (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
- None (open label)
- Enrolment
- 100 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
- Yizhi Liu, M.D,Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230799
- Sponsor's protocol ID
- CCPMOH2017-China-3
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2017
- Last updated
- 17 May 2022
- 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
- ClinicalTrials.gov ID
- NCT03230799
- Acronym / sponsor ID
- CCPMOH2017-China-3
- Conditions
- Congenital Cataract
- Keywords
- congenital cataract, minimal invasive surgery, secondary intraocular lens implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Jul 2017 (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, we have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.
Detailed description
Patients with congenital cataract that requires surgical intervention are enrolled. Then the patients are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional cataract surgery | Active comparator | Procedure: traditional cataract surgeryCentral anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit) |
| minimal invasive lens surgery | Experimental | Procedure: minimal invasive lens surgeryPeripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 1 month and 24 months
- Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
- Informed consent signed by a parent or legal guardian
Key exclusion criteria (10 listed)
- confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract
- Intraocular pressure >21 mmHg
- Preterm birth (<28 weeks)
- Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
- History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
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 |
|---|---|---|
| minimal invasive lens surgeryWe decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. | Procedure or surgery | minimal invasive lens surgery |
| traditional cataract surgeryACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy | Procedure or surgery | traditional cataract surgery |
Primary outcome
Best correctied visual acuity
Time frame: recorded at each follow-up to five years of age.
Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
3 secondary outcomes
High intra-ocular pressure
Time frame: after lens removal to five years of age.
Visual axis opacification
Time frame: after lens removal to five years of age.
Bi-ocular visual function
Time frame: performed when the patient is four years old and five years old.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- 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.
Yizhi Liu, M.D,Ph.D 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 minimal invasive lens surgery and traditional cataract surgery 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 10 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 17 May 2022. 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 Jing Li, M.D (+86-20-87330341, Reviewborad_SYsU@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best correctied visual acuity (time frame: recorded at each follow-up to five years of age.). 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 17 May 2022.