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Retinal DetachmentIRBNCT04168255

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

A study testing Double tamponade in people with Retinal Detachment, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Retinal Detachment
What is being tested?
Double tamponade
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Oct 2017to 30 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Minia University

    Minya, 61519

Other trials in Egypt

About this study

Official title: Perfluorocarbone Liquids for Tamponading Lower Retinal Breaks to Achieve Retinal Reattachment in Eyes of Retinal Detachment With Proliferative Vitreoretinopathy

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.

Read the 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.

Being tested
Double tamponade
Medical subject headings
Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double tamponadeProcedure or surgery

    Double tamponade procedure in retinal detachment with PVR and inferior breaks

Study groups in NCT04168255
Study groupRoleWhat they receive
Retinal detachmentOtherRetinal detachment with proliferative vitreoretinopathy and inferior breaks
Receives: Procedure: Double tamponade

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. retinal reattachment

    to achieve successful retinal reattachment

    Measured: one year

Secondary outcomes (1)
  1. visual acuity

    is to achieve improvement in the visual acuity

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start1 Oct 2017
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Retinal detachment with proliferative vitreoretinopathy and inferior breaks
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168255
Sponsor's protocol ID
Minia University,IRB
Acronym
IRB
Status last verified
Nov 2019
First submitted
16 Nov 2019
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: methdology

Publications

  • 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.

    PubMed 24800216
  • 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.

    PubMed 33083050

Questions about this trial

What is this clinical trial studying?

A study testing Double tamponade in people with Retinal Detachment, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

retinal reattachment (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04168255, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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