Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01959568
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2013-09-29
Brief Title:
Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery
Sponsor:
The SN Fyodorov Eye Microsurgery State Institution
Organization:
The SN Fyodorov Eye Microsurgery State Institution
Study Overview
Official Title:
Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery Randomised Clinical Trial of Safety
Status:
UNKNOWN
Status Verified Date:
2014-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Purpose to assess the efficacy and safety of double tamponade versus silicone oil tamponade
Design parallel-group study with balanced 11 stratified block randomization Eligible participants are all adults aged 18 or over with first diagnosed rhegmatogenous total retinal detachment with retinal breaks located both in upper and lower retina Also investigators include those patients with total retinal detachment with proliferative vitreoretinopathy PVR in which it is impossible to remove epiretinal membranes completely during the surgery with arbitrary retinal breaks localization Exclusion criteria are severe concomitant eye pathologies glaucoma diabetic retinopathy macular hole traumas etc and eye length more than 27mm
Patients are randomized in two groups test group and control group
In the test group patients undergo subtotal vitrectomy epiretinal membrane removal perfluorodecalin PFD tamponade retinal photocoagulation After that the surgeon replaces ½ of PFD volume by conventional SO with density less than one of water The result is vitreous cavity VC filled in a half with PFD and in another half - with SO In the control group patients undergo subtotal vitrectomy epiretinal membrane removal PFD tamponade retinal photocoagulation and PFD-SO exchange so the result is VC filled with conventional or heavy SO depending on predominant retinal breaks location 30 days after the surgery in both groups tamponing agents are removed from VC and VC is filled with sulfur hexafluoride gas SF6 which dissolves during 1 month Follow-up is at least 12 months
Along with standard examinations after SF6 gas dissolution investigators perform spectral optical coherence tomography OCT and microperimetry With OCT investigators measure thickness of retinal inner and outer nuclear layers With microperimetry investigators determine light sensitivity in 12 and 4 zones from the fixation point
Outcome measures reattachment rate best corrected visual acuity BCVA intraocular pressure IOP thicknesses of inner and outer nuclear layers according to the OCT light sensitivity according to microperimetry the rate of cataract formation in phakic eyes and the rate of tamponing agents emulsification
For final analysis each group will include 145 participants
OCT microperimetry data and visual acuity will be compared between the groups using Students t-test proportions will be compared using exact Fishers test
Design parallel-group study with balanced 11 stratified block randomization Eligible participants are all adults aged 18 or over with first diagnosed rhegmatogenous total retinal detachment with retinal breaks located both in upper and lower retina Also investigators include those patients with total retinal detachment with proliferative vitreoretinopathy PVR in which it is impossible to remove epiretinal membranes completely during the surgery with arbitrary retinal breaks localization Exclusion criteria are severe concomitant eye pathologies glaucoma diabetic retinopathy macular hole traumas etc and eye length more than 27mm
Patients are randomized in two groups test group and control group
In the test group patients undergo subtotal vitrectomy epiretinal membrane removal perfluorodecalin PFD tamponade retinal photocoagulation After that the surgeon replaces ½ of PFD volume by conventional SO with density less than one of water The result is vitreous cavity VC filled in a half with PFD and in another half - with SO In the control group patients undergo subtotal vitrectomy epiretinal membrane removal PFD tamponade retinal photocoagulation and PFD-SO exchange so the result is VC filled with conventional or heavy SO depending on predominant retinal breaks location 30 days after the surgery in both groups tamponing agents are removed from VC and VC is filled with sulfur hexafluoride gas SF6 which dissolves during 1 month Follow-up is at least 12 months
Along with standard examinations after SF6 gas dissolution investigators perform spectral optical coherence tomography OCT and microperimetry With OCT investigators measure thickness of retinal inner and outer nuclear layers With microperimetry investigators determine light sensitivity in 12 and 4 zones from the fixation point
Outcome measures reattachment rate best corrected visual acuity BCVA intraocular pressure IOP thicknesses of inner and outer nuclear layers according to the OCT light sensitivity according to microperimetry the rate of cataract formation in phakic eyes and the rate of tamponing agents emulsification
For final analysis each group will include 145 participants
OCT microperimetry data and visual acuity will be compared between the groups using Students t-test proportions will be compared using exact Fishers test
Detailed Description:
The investigators include in the study all successive patients operated by the same surgeon The study takes place in the SN Fyodorov Eye Microsurgery Federal State Institution located in Moscow Russian Federation
Patients are randomized in two groups with stratified block randomization Strata were defined by combination of two binary prognostic factors duration of retinal detachment less than 3 months and 3 months and PVR presentabsent
Early interim analysis will be performed in order to reveal possible adverse effect of long-term PFD tamponade For interim report success will mean the rate of post-surgical BCVA 20200 Groups sizes for interim analysis will be 35 patients in each group For interim analysis the investigators choose group sizes able to reveal 30 absolute difference in functional success rate with one-sided test to detect possible toxicity of double tamponade for the retina having power of 08 and significance level of p005 In the final analysis success will mean retinal reattachment
For final analysis each group will include 145 participants so that the investigators are able to detect 15 difference in reattachment rate with power of 08 and significance level of p005 Group sizes were computed with exact Fishers test function in GPower 317 software Erdfelder Faul Buchner
OCT is performed with Cirrus HD-OCT system Zeiss Meditec Inc Microperimetry is performed with MP-1 microperimeter Nidek All the examinations are assessed by one ophthalmologist
The allocation concealment is implemented with the help of a third party who stores the randomization list and prepares envelopes containing directions what method of tamponade to employ in each particular patient Patients are blind to the method of tamponade
Patients are randomized in two groups with stratified block randomization Strata were defined by combination of two binary prognostic factors duration of retinal detachment less than 3 months and 3 months and PVR presentabsent
Early interim analysis will be performed in order to reveal possible adverse effect of long-term PFD tamponade For interim report success will mean the rate of post-surgical BCVA 20200 Groups sizes for interim analysis will be 35 patients in each group For interim analysis the investigators choose group sizes able to reveal 30 absolute difference in functional success rate with one-sided test to detect possible toxicity of double tamponade for the retina having power of 08 and significance level of p005 In the final analysis success will mean retinal reattachment
For final analysis each group will include 145 participants so that the investigators are able to detect 15 difference in reattachment rate with power of 08 and significance level of p005 Group sizes were computed with exact Fishers test function in GPower 317 software Erdfelder Faul Buchner
OCT is performed with Cirrus HD-OCT system Zeiss Meditec Inc Microperimetry is performed with MP-1 microperimeter Nidek All the examinations are assessed by one ophthalmologist
The allocation concealment is implemented with the help of a third party who stores the randomization list and prepares envelopes containing directions what method of tamponade to employ in each particular patient Patients are blind to the method of tamponade
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None