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

May 27, 2014 updated by: Pavel V. Lyskin, The S.N. Fyodorov Eye Microsurgery State Institution

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Moscow, Russian Federation, 127486
        • Recruiting
        • SN Fyodorov "Eye Microsurgery" State Institution
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pavel V Lyskin, PhD
        • Sub-Investigator:
          • Elena G Kazimirova, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal reattachment rate
Time Frame: in 1 month after tamponade removal.
in 1 month after tamponade removal.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with best corrected visual acuity >/= 20.200
Time Frame: in 1 month after tamponade removal
in 1 month after tamponade removal

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with intraocular pressure >/= 25 mm Hg
Time Frame: in 1 month after tamponade removal.
in 1 month after tamponade removal.
Percentage of phakic eyes in which cataract occurred during tamponade
Time Frame: During tamponade removal.
During tamponade removal.
Percentage of eyes with tamponing substances emulsification
Time Frame: During tamponade removal.
During tamponade removal.
Thickness of retinal inner and outer nuclear layers
Time Frame: in 1 month after tamponade removal
Measured with Optical Coherence Tomography
in 1 month after tamponade removal
Retinal light sensitivity
Time Frame: in 1 month after tamponade removal
Measured with microperimetry
in 1 month after tamponade removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

September 29, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (ESTIMATE)

October 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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