Anterior Segment Changes After Pars Plana Vitrectomy With SO Using AS-OCT

July 26, 2024 updated by: Mohab Mohamed Khairy Talaat, Minia University

Anterior Segment Changes After Pars Plana Vitrectomy With Silicone Oil Tamponade And After Silicone Oil Evacuation Using AS-OCT.

To evaluate changes in ACA induced by pars plana vitrectomy with SO 1000cs injection in vitreo-retinal surgery in phakic eyes using AS-OCT and changes in the IOP preoperatively, post-operatively and post-silicone oil evacuation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Abstract Introduction Ocular hypertension and secondary glaucoma are relatively common and serious complications in silicone filled eyes which may end in blindness. Reports have described the percentage of incidence to be within 3 - 30 % of silicon filled eye which are complicated with secondary glaucoma. [1] Aim of study Evaluation of changes in anterior chamber angle and intra-ocular pressure (IOP) in patients with rhegmatogenous retinal detachment (RRD) who underwent pars plana vitrectomy (PPV) with silicone oil (SO) 1000cs tamponade and after silicone oil evacuation.

Population The study was a prospective interventional study. The study included 30 eyes from 30 patients with rhegmatogenous retinal detachment (RRD) who are going to undergo PPV with SO injection. The study was conducted at Ophthalmology department, Minia University Hospital in Egypt between April 2023 and April 2024.

Study Type

Observational

Enrollment (Actual)

30

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
      • Minya, Egypt, 61519
        • Faculty of medicine ,Minia 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

Sampling Method

Non-Probability Sample

Study Population

Patients who are phakic with rhegmatogenous retinal detachment

Description

Inclusion Criteria:

  • • Patients with rhegmatogenous retinal detachment who are going to undergo vitreoretinal surgery with silicone oil 1000cs injection as tamponade

Exclusion Criteria:

  • Patients with history of intraocular surgery, laser therapy or intravitreal injection.
  • Patients with significant corneal opacity.
  • Patients with ocular diseases as retinal vein occlusion, uveitis and proliferative diabetic retinopathy.
  • Patients with preexisting glaucoma or family history of glaucoma.
  • Patients with nystagmus.
  • Patient with tractional retinal detachment, exudative retinal detachment or intraocular foreign body.
  • Patients with anterior chamber abnormalities including posterior synechia, peripheral anterior synechia, hyphaema and iris abnormalities.
  • Patients with severe proliferative vitreoretinopathy grade C or more.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with RRD who underwent pars plana vitrectomy with
AS-oct measuring the anterior chamber angle and corneal changes after pars plana vitrectomy with silicone oil 1000cs injection
Device: AS-OCT after vitrectomy
AS-OCT is a light based imaging technique of the anterior segment of the eye in this study it is used to measure the anterior chamber angle changes after pars plana vitrectomy.
Other Names:
  • vitrectomy, silicone oil 1000cs, silicone oil evacuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessement of the changes in anterior chamber angle after vitrectomy with silicone oil injection
Time Frame: postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )

Evaluation of changes in the anterior chamber angle parameters after vitrectomy with silicone oil 1000cs injection.

The measures include AOD 500, TISA 500, ACA and CCT The measuring tool is AS-OCT (anterior segment optical coherent topography)
postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )

Collaborators and Investigators

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

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS-OCT after PPV with SO

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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