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Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Primary Purpose

Congenital Cataract

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
minimal invasive lens surgery
traditional cataract surgery
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Cataract focused on measuring congenital cataract, minimal invasive surgery, secondary intraocular lens implantation

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Zhongshan Ophthalmic Center,Sun Yat-sen URecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

traditional cataract surgery

minimal invasive lens surgery

Arm Description

Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)

Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

High intra-ocular pressure
Determined with Tono-Pen tonometer at each follow-up
Visual axis opacification
Determined with slit-lamp photography at each follow-up
Bi-ocular visual function
Determined with synoptophore

Full Information

First Posted
July 17, 2017
Last Updated
May 10, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03230799
Brief Title
Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
Official Title
Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
congenital cataract, minimal invasive surgery, secondary intraocular lens implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
traditional cataract surgery
Arm Type
Active Comparator
Arm Description
Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)
Arm Title
minimal invasive lens surgery
Arm Type
Experimental
Arm Description
Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration
Intervention Type
Procedure
Intervention Name(s)
minimal invasive lens surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
traditional cataract surgery
Intervention Description
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
Primary Outcome Measure Information:
Title
Best correctied visual acuity
Description
Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
Time Frame
recorded at each follow-up to five years of age.
Secondary Outcome Measure Information:
Title
High intra-ocular pressure
Description
Determined with Tono-Pen tonometer at each follow-up
Time Frame
after lens removal to five years of age.
Title
Visual axis opacification
Description
Determined with slit-lamp photography at each follow-up
Time Frame
after lens removal to five years of age.
Title
Bi-ocular visual function
Description
Determined with synoptophore
Time Frame
performed when the patient is four years old and five years old.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Li, M.D
Phone
+86-20-87330341
Email
Reviewborad_SYsU@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D,Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center,Sun Yat-sen U
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, Phd
Phone
+86-20-87330475
Email
gddlht@gmail.com
First Name & Middle Initial & Last Name & Degree
Haotian Lin, PhD
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

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