A pilot study on the use of a perfluorohexyloctane/silicone oil solution as a heavier than water internal tamponade agent

Abstract

Aims: To report a prospective two centred non-comparative interventional pilot study of a solution of perfluorohexyloctane and silicone oil (Densiron-68) as a heavier than water internal tamponade. Methods: 42 consecutive patients were recruited. The indications include proliferative vitreoretinopathy, retinal detachments arising from inferior retinal breaks, and inability to posture. Results: The success rate with one operation using Densiron was 81% and with further surgery 93%. At the end of the study all tamponade agents were removed in 90% of patients. Visual acuity improved from mean logMAR of 1.41 (SD 0.64) to 0.94 (SD 0.57), p = 0.001. There was little evidence of dispersion and excessive inflammation. Conclusion: This new tamponade agent is being compared to conventional silicone oil in a prospective international randomised trial.

Comparison of postoperative intraocular pressure in patients with Densiron-68 vs conventional silicone oil: a case–control study

“…This pilot study involved 42 cases recruited between Rotterdam and Liverpool. 7 In this study, Densiron-68 was used in patients with RD arising from inferior retinal breaks, in patients incapable of sustaining a head-down posture, and in cases complicated by PVR. At 1 week and 1 month after heavy silicone oil (HSO) operation, six patients (14%) had raised intraocular pressure (IOP) and at 3 months after oil removal, three patients (7%) had IOP higher than 30 mmHg.…”

Emulsification of Densiron-68 used in inferior retinal detachment surgery

“…A few studies have reported on the use of 'Heavy Silicone Oil' for RD. [11][12][13][14] Indications for the use of heavy oil includes PVR, RD with inferior breaks and inability to posture. Variable anatomical results have been reported using Densiron with up to 81% reattachment rates with single surgery in one series 11 and 46% reattachment in another, 12 although the latter study recruited only complex PVR cases.…”

“…The propensity for heavy oil to emulsify is felt to be inversely related to the viscosity of its silicone oil component. 11 Densiron contains 30.5% F6H8 and 69.5% 5000 mPAS Silicone oil by volume. Oxane-HD uses an oil-RMN3 mixture, 14 whereas other oils use similar ratios to Densiron with 1000 mPAS silicone oil component substituted to aid injection.…”

“…13 In some series, heavy oil emulsification has been reported to be low, with little or no clinical impact. 11,13,14 However, Sandner and Engelmann 12 reported emulsification of Densiron in seven out of 48 patients with pseudo-hypopyon formation in four patients. For this reason, they routinely performed anterior chamber irrigation upon Densiron removal.…”

“…Densiron-68 is a solution of perfluorohexyloctane (F 6 H 8 ) and 5000 mPas silicone oil, with viscosity 1387 mPas 3 and has been promoted for prolonged inferior retinal tamponade, particularly as it has similar physical properties to silicone oil in terms of the shape of the bubble. 11 Previous studies 11,12 and promotional product literature (Fluoron Co, Neu-Ulm, Germany) claim that clinically significant Densiron emulsification is not seen, although others have reported significant emulsification. 13 We have identified 40 patients with Densiron insertion over a 24-month period.…”