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

Retinal Detachment Clinical Trial

— IRB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168255
• Other study ID #: Minia University,IRB
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Procedure:
• Double tamponade
Double tamponade procedure in retinal detachment with PVR and inferior breaks

Locations

Country	Name	City	State
Egypt	Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retinal reattachment	to achieve successful retinal reattachment	one year
Secondary	visual acuity	is to achieve improvement in the visual acuity	1 year