- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03908359
Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with congenital cataract that requires surgical intervention are enrolled.
Then the participants 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Zhongshan Ophthalmic Center,Sun Yat-sen U
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Microcornea
- Persistent hyperplastic primary vitreous
- Rubella
- Lowe syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: traditional cataract surgery
Central anterior continuous capsulorhexis opening (5-6 mm)+ lens irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit)
|
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
|
EXPERIMENTAL: minimal invasive lens surgery
Peripheral capsulorhexis opening (1.0-1.5 mm)+lens irrigation/aspiration
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity
Time Frame: 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.
|
up to five years of age
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2018-China11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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