New Technique in Congenital/Pediatric Cataract Surgery | NCT05278936

Studies
New Technique in Congenital/Pediatric Cataract Surgery

NCT05278936

Sponsor

Omer Othman Abdullah

Status

Completed

Last Update Posted

May 2, 2022Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Pediatric Cataract
Congenital Cataract

Interventions

The cataract surgery and the anterior vitrectomy

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Feb 23, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

May 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina CenterSponsor-Investigator

Lead Sponsor

Omer Othman AbdullahOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery	Other	Participitant	Other: The cataract surgery and the anterior vitrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The cataract surgery and the anterior vitrectomy	Other	Surgical	A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Slit-lamp examination	To check the intra-ocular lens positioning	The fourth weeks postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Congenital/pediatric cataract

Exclusion Criteria:

Aphakic and pseudophakic

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer Abdullah, M.Sc.	Ibinsina Modern Eye and Retina Center	Principal Investigator
Huseyin Oksuz, MD	Dunya Goz Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ibinsina Modern eye and retina center		Erbil		44001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided