NCT05278936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

February 23, 2022

Last Update Submit

April 26, 2022

Conditions

Pediatric CataractCongenital Cataract

Keywords

Corneoscleral incisionCataract surgeryVitreorrhexisAnterior vitrectomy

Outcome Measures

Primary Outcomes (1)

  • Slit-lamp examination

    To check the intra-ocular lens positioning

    The fourth weeks postoperatively

Study Arms (1)

A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery

OTHER

Participitant

Other: The cataract surgery and the anterior vitrectomy

Interventions

The cataract surgery and the anterior vitrectomyOTHER

Surgical

A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Congenital/pediatric cataract

You may not qualify if:

  • Aphakic and pseudophakic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibinsina Modern eye and retina center

Erbil, 44001, Iraq

Location

Study Officials

  • Omer Abdullah, M.Sc.

    Ibinsina Modern Eye and Retina Center

    PRINCIPAL INVESTIGATOR

  • Huseyin Oksuz, MD

    Dunya Goz Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate consultant ophthalmologist

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 14, 2022

Study Start

January 1, 2021

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)