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Double Retinal Tamponade for Retinal Detachment With PVR and Inferior Breaks. (IRB)

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Double tamponade
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Minia University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Retinal detachment

Arm Description

Retinal detachment with proliferative vitreoretinopathy and inferior breaks

Outcomes

Primary Outcome Measures

retinal reattachment
to achieve successful retinal reattachment

Secondary Outcome Measures

visual acuity
is to achieve improvement in the visual acuity

Full Information

First Posted
November 16, 2019
Last Updated
November 18, 2019
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04168255
Brief Title
Double Retinal Tamponade for Retinal Detachment With PVR and Inferior Breaks.
Acronym
IRB
Official Title
Perfluorocarbone Liquids for Tamponading Lower Retinal Breaks to Achieve Retinal Reattachment in Eyes of Retinal Detachment With Proliferative Vitreoretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients and methods The study includes thirty eyes of 30 patients with dense cataract, retinal detachment (RD) and proliferative vitreoretinopathy (PVR) and inferior breaks (18 females and 12 males) in the period from October, 2017 to August, 2019 at ophthalmology department, Minia University Hospital. Approval of the study was provided by Faculty of Medicine, Research Ethics Committee and it was in agreement with the tents of Declaration of Helsinki and all patients were singed a consent explaining the risk and benefits of their operation. All of the patients was followed for 12 months. Preoperative examinations History taking included age, sex, laterality and systemic diseases and medications. Ophthalmological examinations including visual acuity assessment, IOP measurement, anterior segment slit lamp examinations, Dilated fundus examinations using indirect ophthalmoscope as well as with the auxiliary lenses and slit lamp aid, retinal chart drawing, biometry and ultrasonography if needed. Surgical technique All of cases were done under peribulbar anesthesia. First, phacoemulsification was performed through clear corneal temporal incision with implantation of hydrophobic acrylic IOL in the capsular bag and closure of wound by a 10/0 nylon suture. This was followed by 23-G pars plana vitrectomy. Core vitrectomy was done and triamcinolone acetonide was injected to ensure complete posterior vitreous detachment. All epiretinal membranes were removed helped by the use of membrane blue (trypan blue 0.15%, DORC International). Then, perfluorocarbone liquid (PFCL) was injected to flatten the posterior retina and base vitrectomy was performed helped by scleral depression. More PFCL was injected to drain subretinal fluid through the original retinal breaks. All retinal breaks were surrounded by 3-4 rows of diode endolaser photocoagulation. Then, fluid air exchange was performed to aspirate PFCL leaving a part of it enough to tamponade the lower retinal breaks and 12% C3F8 (perfluoropropane) was injected into the eye. After 2 weeks, the remaining PFCL was aspirated and replaced with 12% C3F8. Post-operative management All patients were given topical prednisolone 1% (Optipred, Jamjoom pharma Co.) eye drops (QID) and tapered through 4-6 weeks, cyclopentolate 0.5 % eye drops (TID), moxifloxacin 0.3 mg (Vigamox, Alcon Co.) eye drops QID for 1 week and Maxitrol ointment (Neomycin sulphate 3.5 mg, Polymyxin B sulphate 10000 IU and dexamethasone 0.1%, Alcon Co) at night for 4 weeks. Follow up visits were advised next postoperative day, one week, , one month, and then each three months for 1 year. All patients underwent full ophthalmologic examination including BCDVA, IOP, anterior segment slit lamp examination, and dilated fundus examination. Baseline results and that of 1, 3 6, 9 months, and 1year were included in the statistical analysis. This study primary outcome is to achieve successful retinal reattachment and the secondary outcome is to achieve improvement in the visual acuity (BCDVA, log MAR). Successful surgery was considered when retinal reattachment was achieved, improvement in the visual acuity without serious complications such as suprachoroidal hemorrhage, retinal detachment or endophthalmitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Retinal detachment with proliferative vitreoretinopathy and inferior breaks
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retinal detachment
Arm Type
Other
Arm Description
Retinal detachment with proliferative vitreoretinopathy and inferior breaks
Intervention Type
Procedure
Intervention Name(s)
Double tamponade
Intervention Description
Double tamponade procedure in retinal detachment with PVR and inferior breaks
Primary Outcome Measure Information:
Title
retinal reattachment
Description
to achieve successful retinal reattachment
Time Frame
one year
Secondary Outcome Measure Information:
Title
visual acuity
Description
is to achieve improvement in the visual acuity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaaban A Elwan, MD
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia University
City
Minya
ZIP/Postal Code
61519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
methdology
IPD Sharing Time Frame
soon and for 2 years
IPD Sharing Access Criteria
Methdology
Citations:
PubMed Identifier
24800216
Citation
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.
Results Reference
background
PubMed Identifier
33083050
Citation
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.
Results Reference
derived

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

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