Double Retinal Tamponade for Retinal Detachment With PVR and Inferior Breaks.

NCT04168255 | Completed DMC

• 1 other identifier: Minia University,IRB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose To evaluate the efficacy of perfluorocarbone liquids (PFCLs) for tamponading lower retinal breaks to achieve retinal reattachment in eyes of retinal detachment with proliferative vitreoretinopathy (PVR) and inferior breaks. Patients and methods The study was prospective non comparative interventional study. It included thirty eyes of 30 patients suffering from retinal detachment with proliferative vitreoretinopathy and inferior breaks attending the ophthalmology department at Minia University Hospital. The mean age was 50.2± 10.63 years, 18 females and 12 males. Double retinal tamponade procedure were done and the patients were followed for one year. The primary outcome was to achieve successful retinal reattachment and the secondary outcome is to achieve improvement in the postoperative visual acuity.

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

• retinal reattachment

  to achieve successful retinal reattachment

  one year

Secondary Outcomes (1)

• visual acuity

  1 year

Study Arms (1)

Retinal detachment

OTHER

Retinal detachment with proliferative vitreoretinopathy and inferior breaks

Procedure: Double tamponade

Interventions

Double tamponade PROCEDURE

Double tamponade procedure in retinal detachment with PVR and inferior breaks

Retinal detachment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients had retinal detachment with mild to moderate PVR and inferior retinal breaks fit for the operation and patients that completed all the required follow up visits.

You may not qualify if:

• Rhegmatogenous retinal detachment without inferior breaks, other causes of retinal detachment; (tractional or exudative), cases of severe PVR and closed funnel, retinal vascular disorders, maculopathies, uveitis, glaucoma, corneal opacities and previous retinal re-attachment surgery.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61519, Egypt

Location

Related Publications (2)

• Yu Q, Liu K, Su L, Xia X, Xu X. Perfluorocarbon liquid: its application in vitreoretinal surgery and related ocular inflammation. Biomed Res Int. 2014;2014:250323. doi: 10.1155/2014/250323. Epub 2014 Mar 30.

  PMID: 24800216 BACKGROUND

• Farouk Abdelkader M, Abd-Elhamid Mehany Elwan S, Shawkat Abdelhalim A. Double Retinal Tamponade for Treatment of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy and Inferior Breaks. J Ophthalmol. 2020 Oct 7;2020:6938627. doi: 10.1155/2020/6938627. eCollection 2020.

  PMID: 33083050 DERIVED

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Shaaban A Elwan, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of ophthalmology

Model Details: Retinal detachment with proliferative vitreoretinopathy and inferior breaks

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 19, 2019
• Study Start: October 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: soon and for 2 years
• Access Criteria: Methdology

Locations

EG (1)