Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04168255
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2019-11-16
Brief Title:
Double Retinal Tamponade for Retinal Detachment With PVR and Inferior Breaks
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Perfluorocarbone Liquids for Tamponading Lower Retinal Breaks to Achieve Retinal Reattachment in Eyes of Retinal Detachment With Proliferative Vitreoretinopathy
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRB
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 502 1063 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
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 502 1063 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 100 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 015 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 05 eye drops TID moxifloxacin 03 mg Vigamox Alcon Co eye drops QID for 1 week and Maxitrol ointment Neomycin sulphate 35 mg Polymyxin B sulphate 10000 IU and dexamethasone 01 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
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 100 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 015 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 05 eye drops TID moxifloxacin 03 mg Vigamox Alcon Co eye drops QID for 1 week and Maxitrol ointment Neomycin sulphate 35 mg Polymyxin B sulphate 10000 IU and dexamethasone 01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None