Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT03908359|
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Cataract||Procedure: traditional cataract surgery Procedure: minimal invasive lens surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||December 2023|
|Active Comparator: traditional cataract surgery||
Procedure: traditional cataract surgery
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
|Experimental: minimal invasive lens surgery||
Procedure: minimal invasive lens 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908359
|Contact: Jing Li, M.D||+86-20-87330341||Reviewborad_SYsU@163.com|
|Zhongshan Ophthalmic Center,Sun Yat-sen U||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Haotian Lin, Phd +86-20-87330475 firstname.lastname@example.org|
|Principal Investigator: Haotian Lin, PhD|
|Principal Investigator: Yizhi Liu, PhD|
|Principal Investigator:||Yizhi Liu, M.D,Ph.D||Zhongshan Ophthalmic Center, Sun Yat-sen University|