Congenital CataractNCT03240796
Secondary Intraocular Lens Implantation in Pediatric Patients
A study testing minimal invasive surgery and secondary IOL implantation and traditional cataract surgery and secondary IOL implantation in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation. Read more about this study
- Who is it for?
- Ages 24 to 72 months
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- minimal invasive surgery and secondary IOL implantation and traditional cataract surgery and secondary IOL implantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to Dec 2019
- 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 24 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian
Who cannot join
- Intraocular pressure >21 mmHg at enrollment 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 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: Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts
This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation.
Read the detailed description
Pediatric patients received minimal invasive surgery and traditional lens removal surgery (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy of primary surgery: Group I: the participants received minimal invasive surgery, while in Group II, the participants received a traditional cataract surgery. Investigators perform a secondary intraocular lens implantation for the patients. Investigators compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups after the first and the second surgery, aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.
- Conditions
- Congenital Cataract
- Being tested
- minimal invasive surgery and secondary IOL implantation, traditional cataract surgery and secondary IOL implantation
- Keywords
- congenital cataract, intra-capsular IOL implantation, ciliary sulcus fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal invasive surgery and secondary IOL implantationProcedure or surgery
We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and 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. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
traditional cataract surgery and secondary IOL implantationProcedure or surgery
traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit).
Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
| Study group | Role | What they receive |
|---|---|---|
| minimal invasive surgery and secondary IOL implantation | Experimental | Not described Receives: Procedure: minimal invasive surgery and secondary IOL implantation |
| traditional cataract surgery and secondary IOL implantation | Active comparator | Not described Receives: Procedure: traditional cataract surgery and secondary IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.
Measured: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Secondary outcomes (3)
Visual axis opacification
Visual axis opacification was recorded by standardized slit lamp retroillumination.
Measured: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
High intraocular pressure
measured with Tono-pen tonometer
Measured: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Bi-ocular visual function
determined with synoptophore
Measured: The examination is performed when the patient is four years old and older, once a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Aug 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- Haotian Lin, M.D,Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240796
- Sponsor's protocol ID
- CCPMOH2017-China-4
- Status last verified
- Apr 2019
- First submitted
- 26 Jul 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts
- ClinicalTrials.gov ID
- NCT03240796
- Acronym / sponsor ID
- CCPMOH2017-China-4
- Conditions
- Congenital Cataract
- Keywords
- congenital cataract, intra-capsular IOL implantation, ciliary sulcus fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Aug 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.
This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation.
Detailed description
Pediatric patients received minimal invasive surgery and traditional lens removal surgery (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy of primary surgery: Group I: the participants received minimal invasive surgery, while in Group II, the participants received a traditional cataract surgery. Investigators perform a secondary intraocular lens implantation for the patients. Investigators compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups after the first and the second surgery, aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimal invasive surgery and secondary IOL implantation | Experimental | Procedure: minimal invasive surgery and secondary IOL implantation |
| traditional cataract surgery and secondary IOL implantation | Active comparator | Procedure: traditional cataract surgery and secondary IOL implantation |
Who may qualify
- Ages
- 24 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian
Key exclusion criteria (1 listed)
- Intraocular pressure >21 mmHg at enrollment 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 Microcornea Persistent hyperplastic primary vitreous Rubella Lowe syndrome
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 surgery and secondary IOL implantationWe decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and 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. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus. | Procedure or surgery | minimal invasive surgery and secondary IOL implantation |
| traditional cataract surgery and secondary IOL implantationtraditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit). Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus. | Procedure or surgery | traditional cataract surgery and secondary IOL implantation |
Primary outcome
Best corrected visual acuity
Time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.
3 secondary outcomes
Visual axis opacification
Time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
High intraocular pressure
Time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Bi-ocular visual function
Time frame: The examination is performed when the patient is four years old and older, once a year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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.
Haotian Lin, 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 surgery and secondary IOL implantation and traditional cataract surgery and secondary IOL implantation 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 1 inclusion and 1 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 10 Apr 2019. 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 corrected visual acuity (time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)). 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 10 Apr 2019.