Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor:
Information provided by (Responsible Party):
Pavel V. Lyskin, The S.N. Fyodorov Eye Microsurgery State Institution
ClinicalTrials.gov Identifier:
NCT01959568
First received: September 29, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Retinal Detachment
Procedure: Vitrectomy and tamponade

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery: Randomised Clinical Trial of Safety

Resource links provided by NLM:


Further study details as provided by The S.N. Fyodorov Eye Microsurgery State Institution:

Primary Outcome Measures:
  • Retinal reattachment rate [ Time Frame: in 1 month after tamponade removal. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with best corrected visual acuity >/= 20.200 [ Time Frame: in 1 month after tamponade removal ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Percentage of patients with intraocular pressure >/= 25 mm Hg [ Time Frame: in 1 month after tamponade removal. ] [ Designated as safety issue: Yes ]
  • Percentage of phakic eyes in which cataract occurred during tamponade [ Time Frame: During tamponade removal. ] [ Designated as safety issue: Yes ]
  • Percentage of eyes with tamponing substances emulsification [ Time Frame: During tamponade removal. ] [ Designated as safety issue: No ]
  • Thickness of retinal inner and outer nuclear layers [ Time Frame: in 1 month after tamponade removal ] [ Designated as safety issue: Yes ]
    Measured with Optical Coherence Tomography

  • Retinal light sensitivity [ Time Frame: in 1 month after tamponade removal ] [ Designated as safety issue: Yes ]
    Measured with microperimetry


Estimated Enrollment: 290
Study Start Date: March 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Double tamponade
Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation. After that the surgeon replaces ½ of perfluorodecalin volume by silicone oil.
Procedure: Vitrectomy and tamponade

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.

Other Names:
  • Perfluorodecalin Dk-Line (Bausch&Lomb)
  • Silicone oil Oxane 1300 (Bausch&Lomb)
  • Silicone oil Oxane HD (Bausch&Lomb)
Active Comparator: Silicone oil tamponade
Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation and perfluorodecalin-silicone oil exchange.
Procedure: Vitrectomy and tamponade

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.

Other Names:
  • Perfluorodecalin Dk-Line (Bausch&Lomb)
  • Silicone oil Oxane 1300 (Bausch&Lomb)
  • Silicone oil Oxane HD (Bausch&Lomb)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults aged 18 or over with firstly diagnosed rhegmatogenous total retinal detachment:

  1. with retinal breaks located both in upper and lower retina; OR
  2. with PVR which was impossible to remove completely during the surgery.

Exclusion Criteria:

  1. severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
  2. eye length more than 27mm.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959568

Contacts
Contact: Pavel V Lyskin, PhD +79165558019 plyskin@yahoo.com
Contact: Elena G Kazimirova, MD +79165898410 lena.kazimirova@gmail.com

Locations
Russian Federation
SN Fyodorov "Eye Microsurgery" State Institution Recruiting
Moscow, Russian Federation, 127486
Contact: Pavel V Lyskin, PhD    +79165558019    plyskin@yahoo.com   
Contact: Elena G Kazimirova, MD    +79165898410    lena.kazimirova@gmail.com   
Principal Investigator: Pavel V Lyskin, PhD         
Sub-Investigator: Elena G Kazimirova, MD         
Sponsors and Collaborators
The S.N. Fyodorov Eye Microsurgery State Institution
Investigators
Principal Investigator: Pavel V Lyskin, PhD SN Fyodorov "Eye Microsurgery" State Institution
Study Director: Valery D Zakharov, Professor SN Fyodorov "Eye Microsurgery" State Institution
  More Information

No publications provided

Responsible Party: Pavel V. Lyskin, Pavel V. Lyskin, MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
ClinicalTrials.gov Identifier: NCT01959568     History of Changes
Other Study ID Numbers: #8, 04/09/2013
Study First Received: September 29, 2013
Last Updated: May 27, 2014
Health Authority: Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation

Keywords provided by The S.N. Fyodorov Eye Microsurgery State Institution:
Retinal Detachment
Double Tamponade
Perfluorocarbon liquids
Vitrectomy

Additional relevant MeSH terms:
Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014