NCT05716971

Brief Summary

Densiron is used as a tamponading agent for inferior retinal detachment with inferior retinal breaks However, data about the use of Densiron -68 for RRD with multiple retinal breaks; especially if involving both superior and inferior quadrants; are not sufficient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 29, 2023

Last Update Submit

January 29, 2023

Conditions

Retinal Detachment Multiple Breaks

Outcome Measures

Primary Outcomes (2)

  • Number of retinal breaks

    ( 2, 3, 4, or more)

    1 month

  • Distribution of retinal breaks

    superior and inferior / inferior only

    1 month

Secondary Outcomes (3)

  • RD Quadrants

    1 month

  • PVR

    1 month

  • - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) Hypotony (IOP < 6 mmHg

    1 month

Study Arms (2)

RD: (study case group A)

Redetachment under Densiron

Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment

RA : (control group B)

reattachment under Densiron

Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment

Interventions

Densiron-68 (heavy silicone oil) tamponade for retinal detachmentPROCEDURE

pars plana vitrectomy using Densiron-68 at thee end of surgery

RA : (control group B)RD: (study case group A)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective review of records of cases of "Rhegmatogenous Retinal Detachment (RRD)with multiple Retinal breaks (MRBs) ", for whom pars plana vitrectomy using Densiron-68 as a tamponading agent had been performed, in the period from March 2014 till November 2019

You may qualify if:

  • \- RRD with multiple retinal breaks (MRBs), using Densiron-68 tamponade.
  • Age= 16 and older

You may not qualify if:

  • \- RRD using conventional silicone oil (SO) or Gas tamponade.
  • RRD with single RBs
  • Age \< 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

Location

MeSH Terms

Interventions

densiron-68densiron

Study Design

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

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

October 1, 2022

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

February 8, 2023

Record last verified: 2023-01

Locations

EG(1)