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

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ClinicalTrials.gov Identifier: NCT01959568
Recruitment Status : Unknown
Verified May 2014 by Pavel V. Lyskin, The S.N. Fyodorov Eye Microsurgery State Institution.
Recruitment status was:  Recruiting
First Posted : October 10, 2013
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Pavel V. Lyskin, The S.N. Fyodorov Eye Microsurgery State Institution

Tracking Information
First Submitted Date  ICMJE September 29, 2013
First Posted Date  ICMJE October 10, 2013
Last Update Posted Date May 28, 2014
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
Retinal reattachment rate [ Time Frame: in 1 month after tamponade removal. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01959568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
Percentage of patients with best corrected visual acuity >/= 20.200 [ Time Frame: in 1 month after tamponade removal ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2013)
  • Percentage of patients with intraocular pressure >/= 25 mm Hg [ Time Frame: in 1 month after tamponade removal. ]
  • Percentage of phakic eyes in which cataract occurred during tamponade [ Time Frame: During tamponade removal. ]
  • Percentage of eyes with tamponing substances emulsification [ Time Frame: During tamponade removal. ]
  • Thickness of retinal inner and outer nuclear layers [ Time Frame: in 1 month after tamponade removal ]
    Measured with Optical Coherence Tomography
  • Retinal light sensitivity [ Time Frame: in 1 month after tamponade removal ]
    Measured with microperimetry
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery.
Official Title  ICMJE Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery: Randomised Clinical Trial of Safety
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Retinal Detachment
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Vitrectomy and tamponade
  • Active Comparator: Silicone oil tamponade
    Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation and perfluorodecalin-silicone oil exchange.
    Intervention: Procedure: Vitrectomy and tamponade
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 9, 2013)
290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01959568
Other Study ID Numbers  ICMJE #8, 04/09/2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pavel V. Lyskin, The S.N. Fyodorov Eye Microsurgery State Institution
Study Sponsor  ICMJE The S.N. Fyodorov Eye Microsurgery State Institution
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pavel V Lyskin, PhD SN Fyodorov "Eye Microsurgery" State Institution
Study Director: Valery D Zakharov, Professor SN Fyodorov "Eye Microsurgery" State Institution
PRS Account The S.N. Fyodorov Eye Microsurgery State Institution
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP