Effect of Intraocular Tamponade on Visual Perception

September 13, 2022 updated by: Ahmed Abdelshafy, Benha University

Effect of Intraocular Tamponade on Visual Function in the Human Eyes

Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy Tabl
        • Contact:
        • Sub-Investigator:
          • Marwa Abdelshafy, MD

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary retinal detachment patients.
  • patients eligible for 23 gauge pars-plana vitrectomy operation.

Exclusion Criteria:

  • patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
  • patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silicon oil group
Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
Diagnostic test: Electroretinogram
Retinal function assessment using electroretinogram
Procedure: Vitrectomy operation
Vitrectomy operation to treat retinal detachment
Active Comparator: Air tamponade
Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.
Diagnostic test: Electroretinogram
Retinal function assessment using electroretinogram
Procedure: Vitrectomy operation
Vitrectomy operation to treat retinal detachment
Active Comparator: Non-expansile gas
Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
Diagnostic test: Electroretinogram
Retinal function assessment using electroretinogram
Procedure: Vitrectomy operation
Vitrectomy operation to treat retinal detachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in visual acuity measured in LogMAR units.
Baseline and monthly after surgery till 6 months of follow up.
Retinal function amplitude
Time Frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.
Baseline and monthly after surgery till 6 months of follow up.
Retinal function implicit time.
Time Frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.
Baseline and monthly after surgery till 6 months of follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.
Baseline and monthly after surgery till 6 months of follow up.

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Ahmed A Tabl, MD, Benha 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)

September 12, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

October 28, 2023

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-10-22

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

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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