Back to resultsNew Technique in Congenital/Pediatric Cataract Surgery
Primary Purpose
Pediatric Cataract, Congenital Cataract
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
The cataract surgery and the anterior vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Cataract focused on measuring Corneoscleral incision, Cataract surgery, Vitreorrhexis, Anterior vitrectomy
Eligibility Criteria
Inclusion Criteria:
- Congenital/pediatric cataract
Exclusion Criteria:
- Aphakic and pseudophakic
Sites / Locations
- Ibinsina Modern eye and retina center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery
Arm Description
Participitant
Outcomes
Primary Outcome Measures
Slit-lamp examination
To check the intra-ocular lens positioning
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05278936
Brief Title
New Technique in Congenital/Pediatric Cataract Surgery
Official Title
A Simplified Sclerocorneal Incision/Tunnel in Performing Congenital/Pediatric Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omer Othman Abdullah
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
In pediatric/congenital cataract surgery; multiple surgical interventions are performed, which needs multiple general anesthesias. Here, we describe a new technique, to end the operation in one session.
Detailed Description
Generally, in congenital/pediatric cataract surgery, it might be possible to different multiple procedures with multiple general anesthesias. Here, the investigators found a new procedure to perform the cataract removal, intraocular implantation, and the anterior vitrectomy all in one session through a sclero-corneal tunnel. The corneoscleral tunnels are covered by the conjunctiva to abolish the need for both suturing and repeated general anesthesia to remove corneal sutures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cataract, Congenital Cataract
Keywords
Corneoscleral incision, Cataract surgery, Vitreorrhexis, Anterior vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery
Arm Type
Other
Arm Description
Participitant
Intervention Type
Other
Intervention Name(s)
The cataract surgery and the anterior vitrectomy
Intervention Description
Surgical
Primary Outcome Measure Information:
Title
Slit-lamp examination
Description
To check the intra-ocular lens positioning
Time Frame
The fourth weeks postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Congenital/pediatric cataract
Exclusion Criteria:
Aphakic and pseudophakic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Abdullah, M.Sc.
Organizational Affiliation
Ibinsina Modern Eye and Retina Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huseyin Oksuz, MD
Organizational Affiliation
Dunya Goz Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ibinsina Modern eye and retina center
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
New Technique in Congenital/Pediatric Cataract Surgery
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