NCT05817630

Brief Summary

Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

April 5, 2023

Last Update Submit

April 17, 2023

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (4)

  • Change in CFT just before SOR (central foveal thickness)

    Change in CFT just before SOR (from baseline fellow eye) (microns, %) (each group)

    baseline to time just before silicone oil removal

  • Change in PFT just before SOR (Parafoveal thickness)

    Change in PFT just before SOR (from baseline fellow eye) (microns, %) (each group)

    baseline to time just before silicone oil removal

  • • Change in CFT after SOR

    • Change in CFT after SOR (from baseline fellow eye) (microns, %) (each group)

    from baseline fellow eye to 1 month after silicone oil removal

  • • Change in PFT after SOR

    • Change in PFT after SOR (from baseline fellow eye) (microns, %) (each group)

    from baseline fellow eye to 1 month after silicone oil removal

Secondary Outcomes (4)

  • • Relative Risk of severe CFT Thinning before SOR (between group A and B)

    baseline to time just before silicone oil removal

  • • Relative Risk of severe PFT Thinning before SOR (between group A and B

    baseline to time just before silicone oil removal

  • • Relative Risk of severe CFT Thinning after SOR (between group A and B)

    from baseline fellow eye to 1 month after silicone oil removal

  • • Relative Risk of severe PFT Thinning after SOR (between group A and B)

    from baseline fellow eye to 1 month after silicone oil removal

Study Arms (2)

Group A

Group A: 3 months SO Tamponade

Other: Silicone oil Tamponade for Retinal Detachment

Group B

Group B: 6 months SO Tamponade

Other: Silicone oil Tamponade for Retinal Detachment

Interventions

Silicone oil Tamponade for Retinal DetachmentOTHER

eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed

Group AGroup B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.

You may qualify if:

  • Silicone oil (SO) tamponade ( up to 6 months)
  • Attached retina under SO
  • Attached retina 3 months after Silicone oil Removal (SOR)
  • Normal fellow eye ( no retinal detachment or macular disease)
  • OCT scan performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)

You may not qualify if:

  • Rhegmatogenous Retinal Detachment (RRD) with other tamponades ( e.g.: Gas, Densiron)
  • SO tamponade less than 3 months, or more than 6 months
  • Recurrent RD under SO
  • Recurrent RD within 3 months after SOR
  • One eyed
  • Vitrectomized fellow eye
  • Retinal detachment, or macular disease in the fellow eye.
  • Posterior staphyloma
  • Anisometropia (history, refraction if possible, spectacles prescription)
  • Absence of any of the OCT scans performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

Location

Related Publications (1)

  • Ewais WA, Ali LS, Aboalazayem FM. Impact of duration of silicone oil tamponade on foveal and parafoveal thickness in rhegmatogenous retinal detachment: a retrospective cohort study. Int Ophthalmol. 2024 Apr 2;44(1):167. doi: 10.1007/s10792-024-03096-8.

    PMID: 38565753DERIVED

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology Cairo university

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

February 15, 2023

Primary Completion

April 1, 2023

Study Completion

April 5, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)