Short-term Anterior Segment Changes After Pars Plana Vitrectomy (PPV) and Silicone Oil (SO) Tamponade, Anterior Segment OCT (AS-OCT) Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-12-01

Brief Summary

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The purpose of our study is to utilize AS-OCT to analyze the anterior segment morphological changes in the early postoperative period of patients who will undergo PPV with silicone oil injection.

Detailed Description

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1. Type of the study: A prospective comparative study.
2. Study Setting: Assiut university hospital.
3. Study subjects:

1. Inclusion criteria:

Patients suffering from different vitreo-retinal disorders (rhegmatogenous retinal detachment, diabetic vitreous hemorrhage, diabetic tractional retinal detachment) with either preserved crystalline lens or previous cataract surgery (at least 3 months prior to PPV) will be recruited
2. Exclusion criteria:

Patient with previous history of ocular trauma, co-existing glaucoma, co-existing anterior uveitis, complicated cataract surgery, IOL-related complications, previous vitreo-retinal surgery, visually significant cataract (necessitating combined phacoemulsification with PPV and SO) and significant corneal opacity will be excluded. If any significant post-PPV complication develops, patient will be excluded from the study.
3. Sample Size Calculation:

Thirty eyes (30 patients) will undergo PPV with SO tamponade and AS-OCT analysis prior to surgery and 1 week post-operatively to achieve study power of 80% with 0.05 significance.

4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): All participants underwent best-corrected visual acuity (BCVA) by Snellen's chart, Slit lamp assessment of the anterior segment, dilated fundus examination, intra-ocular pressure (IOP) measurement by calibrated Goldmann Applanation Tonometer (GAT). Baseline Ophthalmic ultrasound and Axial length measurement will be obtained.

Anterior segment OCT (AS-OCT) protocol All eyes will be examined by AS-OCT (Nidek RS-3000 Advance, Tokyo, Japan) 1-2 days prior to vitreo-retinal surgery and one week after surgery by single experienced physician. Poor fixation or poor image signal (less than 3/10) will exclude the patient from the study.

Anterior segment OCT (AS-OCT) parameters The following anterior segment parameters will be evaluated; central and peripheral anterior chamber depth (cACD, pACD), anterior chamber angle (ACA) and central corneal thickness (CCT).

5 -Research outcome measures:



1. Primary (main):

Mean change in central anterior chamber depth after PPV with SO tamponade.
2. Secondary (subsidiary):

Mean change in peripheral anterior chamber depth, mean change in anterior chamber angle and mean change anterior chamber angle entry area.

Conditions

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ASOCT Changes After Vitrectomy and Silicone Oil Injection

Keywords

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ASOCT, vitrectomy, silicone oil injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Interventions

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vitrectomy and silicone oil injection

Parsplana vitrectomy and silicone oil injection

Intervention Type PROCEDURE

Other Intervention Names

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PPV and SOI

Eligibility Criteria

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Inclusion Criteria

Patients suffering from different vitreo-retinal disorders (rhegmatogenous retinal detachment, diabetic vitreous hemorrhage, diabetic tractional retinal detachment) with either preserved crystalline lens or previous cataract surgery (at least 3 months prior to PPV) will be recruited

Exclusion Criteria

Patient with previous history of ocular trauma, co-existing glaucoma, co-existing anterior uveitis, complicated cataract surgery, IOL-related complications, previous vitreo-retinal surgery, visually significant cataract (necessitating combined phacoemulsification with PPV and SO) and significant corneal opacity will be excluded. If any significant post-PPV complication develops, patient will be excluded from the study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Sarah Alaa Ezzat Abdelmoneim

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ASOCT changes after vitrectomy

Identifier Type: -

Identifier Source: org_study_id