Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery.
1 other identifier
interventional
290
1 country
1
Brief Summary
Purpose: to assess the efficacy and safety of double tamponade versus silicone oil tamponade. Design: parallel-group study with balanced \[1:1\] 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 Student's t-test; proportions will be compared using exact Fisher's test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMay 28, 2014
May 1, 2014
7.5 years
September 29, 2013
May 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retinal reattachment rate
in 1 month after tamponade removal.
Secondary Outcomes (1)
Percentage of patients with best corrected visual acuity >/= 20.200
in 1 month after tamponade removal
Other Outcomes (5)
Percentage of patients with intraocular pressure >/= 25 mm Hg
in 1 month after tamponade removal.
Percentage of phakic eyes in which cataract occurred during tamponade
During tamponade removal.
Percentage of eyes with tamponing substances emulsification
During tamponade removal.
- +2 more other outcomes
Study Arms (2)
Double tamponade
EXPERIMENTALVitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation. After that the surgeon replaces ½ of perfluorodecalin volume by silicone oil.
Silicone oil tamponade
ACTIVE COMPARATORVitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation and perfluorodecalin-silicone oil exchange.
Interventions
In the double tamponade arm the result of surgery is vitreous cavity filled in a half with perfluorodecalin and in another half - with silicone oil. In the silicone oil tamponade arm the result of surgery is vitreous cavity filled with "conventional" or heavy silicone oil, depending on predominant retinal breaks location.
Eligibility Criteria
You may qualify if:
- Adults aged 18 or over with firstly diagnosed rhegmatogenous total retinal detachment:
- with retinal breaks located both in upper and lower retina; OR
- with PVR which was impossible to remove completely during the surgery.
You may not qualify if:
- severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
- eye length more than 27mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SN Fyodorov "Eye Microsurgery" State Institution
Moscow, 127486, Russia
Related Publications (1)
Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
PMID: 32408387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavel V Lyskin, PhD
SN Fyodorov "Eye Microsurgery" State Institution
- STUDY DIRECTOR
Valery D Zakharov, Professor
SN Fyodorov "Eye Microsurgery" State Institution
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pavel V. Lyskin, MD, PhD
Study Record Dates
First Submitted
September 29, 2013
First Posted
October 10, 2013
Study Start
March 1, 2010
Primary Completion
September 1, 2017
Study Completion
June 1, 2018
Last Updated
May 28, 2014
Record last verified: 2014-05