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

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.

Conditions

• Retinal Detachment

Interventions

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.

Sponsors & Collaborators

• The S.N. Fyodorov Eye Microsurgery State Institution

  lead OTHER_GOV

Principal Investigators

• Pavel V Lyskin, PhD · SN Fyodorov "Eye Microsurgery" State Institution

• Valery D Zakharov, Professor · SN Fyodorov "Eye Microsurgery" State Institution

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2017-09-30

Completion

2018-06-30

Countries

• Russia

Study Locations