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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05599854
Collaborator
(none)
30
Enrollment
37
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: vitrectomy and silicone oil injection
 N/A

Detailed Description

  1. Type of the study: A prospective comparative study.

  2. Study Setting: Assiut university hospital.

  3. Study subjects:

  4. 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

  1. 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.

  1. 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.

  1. Secondary (subsidiary):

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Short-term Anterior Segment Changes After Pars Plana Vitrectomy (PPV) and Silicone Oil (SO) Tamponade, Anterior Segment OCT (AS-OCT) Study.
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Outcome Measures

Primary Outcome Measures

  1. central anterior chamber depth [1 week]

    Mean change in central anterior chamber depth after PPV with SO tamponade.

Secondary Outcome Measures

  1. peripheral anterior chamber depth [1 week]

    Mean change in peripheral anterior chamber depth

  2. anterior chamber angle [1 week]

    mean change in anterior chamber angle

  3. anterior chamber angle entry area [1 week]

    mean change anterior chamber angle entry area

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sarah Alaa Ezzat Abdelmoneim, Dr., Assiut University
ClinicalTrials.gov Identifier:
NCT05599854
Other Study ID Numbers:
  • ASOCT changes after vitrectomy
First Posted:
Oct 31, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Alaa Ezzat Abdelmoneim, Dr., Assiut University
ASOCT, vitrectomy, silicone oil injection

Study Results

No Results Posted as of Oct 31, 2022