Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03908359

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Previously, the investigators 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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Procedure: traditional cataract surgery Procedure: minimal invasive lens surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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)	Procedure: traditional cataract surgery 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	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.

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)

Procedure: traditional cataract surgery

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

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.

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center,Sun Yat-sen U	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Yizhi Liu, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haotian Lin, Clinical Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03908359

Other Study ID Numbers:

CCPMOH2018-China11

First Posted:

Apr 9, 2019

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University

Congenital Cataract

minimal invasive surgery

secondary intraocular lens implantation

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Apr 27, 2022