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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.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05599854
Enrollment
30
Registered
2022-10-31
Start date
2022-11-01
Completion date
2025-12-01
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASOCT Changes After Vitrectomy and Silicone Oil Injection

Keywords

ASOCT, vitrectomy, silicone oil injection

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.

Detailed description

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.

Interventions

PROCEDUREvitrectomy and silicone oil injection

Parsplana vitrectomy and silicone oil injection

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
central anterior chamber depth1 weekMean change in central anterior chamber depth after PPV with SO tamponade.

Secondary

MeasureTime frameDescription
peripheral anterior chamber depth1 weekMean change in peripheral anterior chamber depth
anterior chamber angle1 weekmean change in anterior chamber angle
anterior chamber angle entry area1 weekmean change anterior chamber angle entry area

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026