Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber

December 18, 2024 updated by: Zagazig University

Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber with and Without Limited Anterior Pars Plana Vitrectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. This study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber.

Methods: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44511
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cataract with limited anterior pars plana vitrectomy
group I included twelve patients who underwent phacoemulsification combined with limited anterior pars plana vitrectomy
Procedure: cataract surgery 1
Cataract with limited anterior pars plana vitrectomy
Active Comparator: Cataract without limited anterior pars plana vitrectomy
group II included twelve patients that underwent phacoemulsification only
Procedure: cataract surgery 2
cataract without limited anterior pars plana vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central corneal thickness in micrometers.
Time Frame: 6 months
Central corneal thickness in both groups measured by anterior segment OCT
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Mahmoud Mohammad Gamal Mohammad Gamal, MBBCh, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #467/24-June-2024.
  • Zagazig university (Other Identifier: Zagazig university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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