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Secondary Intraocular Lens Implantation in Pediatric Patients

Primary Purpose

Congenital Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
minimal invasive surgery and secondary IOL implantation
traditional cataract surgery and secondary IOL implantation
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, intra-capsular IOL implantation, ciliary sulcus fixation

Eligibility Criteria

24 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian

Exclusion Criteria:

  • 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

Sites / Locations

  • Zhongshan Ophthalmic Center,Sun Yat-sen URecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

minimal invasive surgery and secondary IOL implantation

traditional cataract surgery and secondary IOL implantation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual axis opacification
Visual axis opacification was recorded by standardized slit lamp retroillumination.
High intraocular pressure
measured with Tono-pen tonometer
Bi-ocular visual function
determined with synoptophore

Full Information

First Posted
July 26, 2017
Last Updated
April 9, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03240796
Brief Title
Secondary Intraocular Lens Implantation in Pediatric Patients
Official Title
Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
congenital cataract, intra-capsular IOL implantation, ciliary sulcus fixation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
minimal invasive surgery and secondary IOL implantation
Arm Type
Experimental
Arm Title
traditional cataract surgery and secondary IOL implantation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
minimal invasive surgery and secondary IOL implantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
traditional cataract surgery and secondary IOL implantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.
Time Frame
recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Secondary Outcome Measure Information:
Title
Visual axis opacification
Description
Visual axis opacification was recorded by standardized slit lamp retroillumination.
Time Frame
recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Title
High intraocular pressure
Description
measured with Tono-pen tonometer
Time Frame
recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Title
Bi-ocular visual function
Description
determined with synoptophore
Time Frame
The examination is performed when the patient is four years old and older, once a year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian Exclusion Criteria: 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
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
Haotian Lin, 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

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Secondary Intraocular Lens Implantation in Pediatric Patients

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