NCT06745596

Brief Summary

Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration 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

March 22, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

December 6, 2024

Last Update Submit

December 18, 2024

Conditions

Cataract

Keywords

Limited anterior pars plana vitrectomy

Outcome Measures

Primary Outcomes (1)

  • Central corneal thickness in micrometers.

    Central corneal thickness in both groups measured by anterior segment OCT

    6 months

Study Arms (2)

Cataract with limited anterior pars plana vitrectomy

ACTIVE COMPARATOR

group I included twelve patients who underwent phacoemulsification combined with limited anterior pars plana vitrectomy

Procedure: cataract surgery 1

Cataract without limited anterior pars plana vitrectomy

ACTIVE COMPARATOR

group II included twelve patients that underwent phacoemulsification only

Procedure: cataract surgery 2

Interventions

cataract surgery 1PROCEDURE

Cataract with limited anterior pars plana vitrectomy

Cataract with limited anterior pars plana vitrectomy
cataract surgery 2PROCEDURE

cataract without limited anterior pars plana vitrectomy

Cataract without limited anterior pars plana vitrectomy

Eligibility Criteria

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

You may qualify if:

  • Anterior chamber depth of less than 2.8 mm associated with cataract

You may not qualify if:

  • Mature cataract
  • History of previous ocular surgery
  • Posterior segment pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Mahmoud Mohammad Gamal Mohammad Gamal, MBBCh

    Zagazig University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 20, 2024

Study Start

March 22, 2022

Primary Completion

February 2, 2024

Study Completion

June 24, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)