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Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Primary Purpose

Congenital Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
new surgical procedure
traditional surgical procedure
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, Triamcinolone

Eligibility Criteria

3 Months - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 3 months and 13 years
  2. Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
  3. Informed consent signed by a parent or legal guardian

Exclusion Criteria:

  1. Intraocular pressure >21 mmHg
  2. Preterm birth (<28 weeks)
  3. Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
  4. History of ocular trauma
  5. Previous intraocular surgery

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Cataract Surgery

Traditional Cataract Surgery

Arm Description

Traditional surgery combined triamcinolone staining of the anterior vitreous (TA)

For patients younger than 2 years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + A-vit) For patients older than 2years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + primary intraocular lens implantation + anterior vitrectomy (ACCC+ I/A + PCCC + IOL + A-vit)

Outcomes

Primary Outcome Measures

incidence of high intraocular pressure
Determined with the Tono-pen.
incidence of visual axis opacification
Visual axis obscuration will be evaluated based on the retroillumination.
incidence of uveitis and iris/pupil abnormality
Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.

Secondary Outcome Measures

Best corrected visual acuity
Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
Central corneal thickness
Determined with the pentacam.
Central macular thickness
Determined with the optical coherence tomography.

Full Information

First Posted
March 25, 2020
Last Updated
June 2, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04323982
Brief Title
Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining
Official Title
Comparison of Traditional Cataract Surgery and Traditional Surgery Combine Triamcinolone Staining of the Anterior Vitreous in Treating Congenital Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
March 25, 2021 (Anticipated)
Study Completion Date
March 25, 2021 (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, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.
Detailed Description
Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery. In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
congenital cataract, Triamcinolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New Cataract Surgery
Arm Type
Experimental
Arm Description
Traditional surgery combined triamcinolone staining of the anterior vitreous (TA)
Arm Title
Traditional Cataract Surgery
Arm Type
Active Comparator
Arm Description
For patients younger than 2 years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + A-vit) For patients older than 2years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + primary intraocular lens implantation + anterior vitrectomy (ACCC+ I/A + PCCC + IOL + A-vit)
Intervention Type
Procedure
Intervention Name(s)
new surgical procedure
Intervention Description
(ACCC + I / A + PCCC + TA+ A-vit) or (ACCC + I / A + PCCC + IOL + TA + A-vit)
Intervention Type
Procedure
Intervention Name(s)
traditional surgical procedure
Intervention Description
(ACCC + I / A + PCCC + A-vit) or (ACCC + I / A + PCCC + IOL + A-vit)
Primary Outcome Measure Information:
Title
incidence of high intraocular pressure
Description
Determined with the Tono-pen.
Time Frame
5 years
Title
incidence of visual axis opacification
Description
Visual axis obscuration will be evaluated based on the retroillumination.
Time Frame
5 years
Title
incidence of uveitis and iris/pupil abnormality
Description
Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Best corrected 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
5 years
Title
Central corneal thickness
Description
Determined with the pentacam.
Time Frame
5 years
Title
Central macular thickness
Description
Determined with the optical coherence tomography.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 3 months and 13 years Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity) Informed consent signed by a parent or legal guardian Exclusion Criteria: Intraocular pressure >21 mmHg Preterm birth (<28 weeks) Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy) History of ocular trauma Previous intraocular surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Qiwei, MD
Phone
+86-13924025677
Email
wang_qiwei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Weirong, MD
Organizational Affiliation
SunYat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiwei Wang, M.D., Ph.D
Phone
+ 86-13924025677
Email
wang_qiwei@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.gzzoc.com/
Description
Homepage of Zhongshan Ophthalmic Center

Learn more about this trial

Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

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