Retinal DetachmentNCT01959568
Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery.
A study testing Vitrectomy and tamponade in people with Retinal Detachment, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Vitrectomy and tamponade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2010to Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
- eye length more than 27mm.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
SN Fyodorov "Eye Microsurgery" State Institution
Moscow, 127486
Pavel V Lyskin, PhD, +79165558019, plyskin@yahoo.com
Elena G Kazimirova, MD, +79165898410, lena.kazimirova@gmail.com
About this study
Official title: Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery: Randomised Clinical Trial of Safety
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.
Read more
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.
Read the detailed description
The investigators include in the study all successive patients operated by the same surgeon. The study takes place in the S.N. 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 (present/absent).
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 >/= 20.200. 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 0.8 and significance level of p=0.05. 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 0.8 and significance level of p=0.05. Group sizes were computed with exact Fisher's test function in G*Power 3.1.7 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.
- Conditions
- Retinal Detachment
- Being tested
- Vitrectomy and tamponade
- Keywords
- Retinal Detachment, Double Tamponade, Perfluorocarbon liquids, Vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy and tamponadeProcedure or surgery
Also called Perfluorodecalin Dk-Line (Bausch&Lomb), Silicone oil Oxane 1300 (Bausch&Lomb), Silicone oil Oxane HD (Bausch&Lomb)
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.
| Study group | Role | What they receive |
|---|---|---|
| Double tamponade | Experimental | Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation. After that the surgeon replaces ½ of perfluorodecalin volume by silicone oil. Receives: Procedure: Vitrectomy and tamponade |
| Silicone oil tamponade | Active comparator | Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation and perfluorodecalin-silicone oil exchange. Receives: Procedure: Vitrectomy and tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal reattachment rate
Measured: in 1 month after tamponade removal.
Secondary outcomes (1)
Percentage of patients with best corrected visual acuity >/= 20.200
Measured: in 1 month after tamponade removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startMar 2010
- Primary completionSep 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pavel V. Lyskin, The S.N. Fyodorov Eye Microsurgery State Institution
- Investigators
- Pavel V Lyskin, PhD, Principal investigator, SN Fyodorov "Eye Microsurgery" State InstitutionValery D Zakharov, Professor, Study director, SN Fyodorov "Eye Microsurgery" State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959568
- Sponsor's protocol ID
- #8, 04/09/2013
- Status last verified
- May 2014
- First submitted
- 29 Sep 2013
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32408387
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery: Randomised Clinical Trial of Safety
- ClinicalTrials.gov ID
- NCT01959568
- Acronym / sponsor ID
- #8, 04/09/2013
- Conditions
- Retinal Detachment
- Keywords
- Retinal Detachment, Double Tamponade, Perfluorocarbon liquids, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Study start
- Mar 2010
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators include in the study all successive patients operated by the same surgeon. The study takes place in the S.N. 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 (present/absent).
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 >/= 20.200. 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 0.8 and significance level of p=0.05. 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 0.8 and significance level of p=0.05. Group sizes were computed with exact Fisher's test function in G*Power 3.1.7 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double tamponade | Experimental | Procedure: Vitrectomy and tamponadeVitrectomy 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 comparator | Procedure: Vitrectomy and tamponadeVitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation and perfluorodecalin-silicone oil exchange. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with retinal breaks located both in upper and lower retina; OR
- with PVR which was impossible to remove completely during the surgery.
Key exclusion criteria (2 listed)
- severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
- eye length more than 27mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitrectomy and tamponadeAlso: Perfluorodecalin Dk-Line (Bausch&Lomb), Silicone oil Oxane 1300 (Bausch&Lomb), Silicone oil Oxane HD (Bausch&Lomb)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. | Procedure or surgery | Double tamponade, Silicone oil tamponade |
Primary outcome
Retinal reattachment rate
Time frame: in 1 month after tamponade removal.
1 secondary outcome
Percentage of patients with best corrected visual acuity >/= 20.200
Time frame: in 1 month after tamponade removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Derived from this study: PubMed 32408387Schwartz 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.
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RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
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Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel V Lyskin, PhD principal investigator
SN Fyodorov "Eye Microsurgery" State Institution
Valery D Zakharov, Professor study director
SN Fyodorov "Eye Microsurgery" State Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy and tamponade in people with Retinal Detachment, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 May 2014. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel V Lyskin, PhD (+79165558019, plyskin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal reattachment rate (time frame: in 1 month after tamponade removal.). 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 NCT01959568, which also lists 1 linked publication.
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 28 May 2014.