Densiron 68

Cillino S et al.:

TREATMENT OF PERSISTENTLY OPEN MACULAR HOLES WITH HEAVY SILICONE OIL (DENSIRON 68) VERSUS C2F6. A PROSPECTIVE RANDOMIZED STUDY.

Retina. 2016 Apr;36(4):688-94. doi: 10.1097/IAE.0000000000000781.

PURPOSE:
To compare the efficacy of a mixture of silicone oil and perfluorohexyloctane (Densiron 68) with C2F6 gas endotamponade in the retreatment of persistently open full-thickness macular holes.

METHODS:
In this prospective randomized study, 21 consecutive patients who were unsuccessfully operated on for large idiopathic full-thickness macular hole were randomly assigned to undergo a second vitrectomy with 20% perfluoroethane gas (C2F6, Group A) or with Densiron 68 tamponade (Group B).

PRIMARY OUTCOMES:
Endpoint (12 months) full-thickness macular hole closure rate by spectral domain optical coherence tomography and logMAR corrected distance visual acuity.

SECONDARY OUTCOMES:
postoperative adverse events.

RESULTS:
The mean diameter of macular holes before the second pars plana vitrectomy was 680.3 ± 120.8 μm and 740.5 ± 105.3 μm in Groups A and B, respectively (P = 0.237); mean preoperative corrected distance visual acuity was 0.96 ± 0.36 logMAR and 1.12 ± 0.35 logMAR, respectively (P = 0.315). Endpoint full-thickness macular hole closure was obtained in 30% of patients (3/10) in Group A and in 82% (9/11) in Group B (P = 0.030). Corrected distance visual acuities were, respectively, 0.80 ± 0.25 logMAR and 0.55 ± 0.20 logMAR, with significant intergroup difference (P = 0.019); corrected distance visual acuity increased in Group B only (P = 0.003). No differences in complications were found.

CONCLUSION:
The results indicate that Densiron 68 tamponade could be a useful, safe, and more efficacious method than gas tamponade to retreat persisting macular holes.

zum Artikel

Liu F et al.:

ANATOMICAL AND FUNCTIONAL OUTCOMES AFTER DENSIRON 68 HEAVY SILICONE OIL TAMPONADE FOR COMPLICATED RETINAL DETACHMENT IN CHINESE EYES.

Int J Ophthalmol 2014; 7(3): 469-73.

AIM
To evaluate the safety and efficacy of Densiron 68 heavy silicone oil (HSO) tamponade for complicated retinal detachment (RD) in Chinese eyes.

METHODS
Twenty-one eyes of 21 patients with complicated RD were included in this retrospective study. All patients underwent pars plana vitrectomy with an internal tamponade using Densiron 68 HSO. Anatomical and functional results and complications were evaluated, including retinal status, visual acuity (VA), intraocular pressure (IOP), intraocular inflammation, lens opacity, and HSO emulsification.

RESULTS
All the patients were followed up for 3mo to 1y (5.8±1.16mo). Retinal reattachment was achieved in 19 of 21 patients (90.5%). VA improved in 18 of 21 patients (85.7%), from 1.93 logMAR (±0.48) to 1.52 logMAR (±0.45) (P=0.001). Postoperative complications included early dispersion of HSO in 7 eyes (38.8%), cataract in 10 of 18 phakic eyes (55.5%), moderate postoperative inflammation reaction in 10 eyes (47.6%), and elevated IOP in 5 eyes (23.8%), all of which were controlled by medication or by surgery.

CONCLUSION
High anatomical and functional success rates can be achieved with primary vitrectomy for complicated RD by using Densiron 68 HSO; however, it should not be ignored that Densiron 68 HSO can cause some complications in the eye.

zum Artikel

Levasseur SD et al.:

HIGH-DENSITY SILICONE OIL DENSIRON-68 AS AN INTRAOCULAR TAMPONADE FOR PRIMARY INFERIOR RETINAL DETACHMENTS.

Retina 2013; 33(3): 627-33.

PURPOSE:
To evaluate the effectiveness and safety of the heavy silicone oil Densiron-68 as an internal retinal tamponade after vitrectomy in patients with primary inferior rhegmatogenous retinal detachment.

METHODS:
A retrospective consecutive case series involving inferior rhegmatogenous retinal detachment in 42 patients recruited between 2007 and 2010 was completed. All patients underwent primary vitrectomy followed by injection of Densiron-68. Each patient was then examined at 1 week, 1 month, 3 months, and 6 months after its removal. Included patients had a rhegmatogenous retinal detachment with at least 1 retinal break between 4 and 8 clock hours and completed 6 months of follow-up after removal of Densiron-68. Assessments for reattachment of the retina, visual acuity, and any complications from the surgery were recorded.

RESULTS:
Thirty-nine of 42 patients completed all follow-up visits. Anatomical success was achieved in 85% (33 of 39) of cases with one procedure, increasing to 95% (37 of 39) with additional surgery. The mean visual acuity improved from mean logarithm of the minimum angle of resolution of 1.29 ± 0.61 preoperatively to 0.87 ± 0.67 postoperatively. The most common complications were cataracts (83%, 10 of 12), posterior capsular opacification (22%, 6 of 27), and ocular hypertension (15%, 6 of 39).

CONCLUSION:
High anatomical success rates can be achieved with primary vitrectomy for inferior rhegmatogenous retinal detachment with the use of Densiron-68.

zum Artikel

Avitabile T et al.:

HEAVY VERSUS STANDARD SILICONE OIL IN THE MANAGEMENT OF RETINAL DETACHMENT WITH MACULAR HOLE IN MYOPIC EYES.

Retina 2011; 31(3): 540-6.

PURPOSE:
The purpose of this study was to compare pars plana vitrectomy (PPV) with 1000 cSt silicone oil endotamponade and PPV with densiron endotamponade for retinal detachment with macular hole and posterior staphyloma in highly myopic eyes.

PATIENTS AND METHODS:
In a prospective study, 30 eyes of 30 patients were randomly assigned to PPV and densiron (n = 15) or PPV with silicone oil (n = 15). All eyes had laser photocoagulation of the macular hole rim after PPV. Silicone oil or densiron was removed 12 weeks after surgery. Patients were followed-up for 6 months after oil removal.

RESULTS:
In the densiron group, the retinal reattachment rate was 100% with densiron in situ and 87% after its removal, and in the silicone oil group, the retinal reattachment rate was 67% with silicone oil in situ and 53.4% after oil removal. Thus, PPV with densiron had a better anatomical success rate than silicone oil (P = 0.04 with endotamponade and P = 0.05 after endotamponade removal). In both groups, paired comparison of preoperative and postoperative best-corrected visual acuity was not statistically significant (P = 0.08).

CONCLUSION:
Pars plana vitrectomy with densiron is a preferred surgical procedure for the repair of macular hole retinal detachment in highly myopic eyes with posterior staphyloma.

zum Artikel

Joussen AM, Rizzo S, Kirchhof B, Schrage N, Li X, Lente C, Hilgers RD; HSO -Study Group.:

HEAVY SILICONE OIL VERSUS STANDARD SILICONE OIL IN AS VITREOUS TAMPONADE IN INFERIOR PVR (HSO STUDY): INTERIM ANALYSIS.

Acta Ophthalmol 2011; 89(6): e483-9

PURPOSE:
The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO study) is designed to answer the question whether a heavier-than-water tamponade improves the prognosis of eyes with proliferative vitreoretinopathy (PVR) of the lower retina.

METHODS:
The HSO Study is a multicentre, randomized, prospective, controlled clinical trial stratified by surgeon comparing two endotamponades within a two-arm parallel-group design. Patients with inferiorly and posteriorly located PVR grade C-A6 were randomized to either HSO or standard silicone oil as a tamponading agent. The main end-point criteria are complete retinal attachment at 12 months and change in visual acuity (VA) 12 months postoperatively compared to the preoperative VA.

RESULTS:
Forty-six patients treated with HSO were compared to 47 patients treated with standard silicone oil. There was no difference among the groups regarding baseline data. Three patients in the HSO and five patients in the standard silicone oil group fulfilled intraoperative exclusion criteria. There was no significant difference between both groups regarding anatomical success. Neither noninferiority nor superiority was shown with regard to final acuity.

CONCLUSIONS:
The HSO Study is the first randomized prospective clinical trial to compare heavy and standard silicone oil in patients with PVR of the lower retina. The intermediate results failed to demonstrate superiority of a heavy tamponade.

zum Artikel

Kirchhof B.:

VOR- UND NACHTEILE DES SCHWEREN SILIKONÖLS.

Ophthalmologe 2010; 107(6): 566, 568-70.

ABSTRACT:
Heavy silicone oil does not have any evidence-based advantages or disadvantages over conventional silicone oil. It is up to the surgeon to choose the type of tamponade considered to be most suitable for the individual eye. Suitable indications for heavy silicone oil are, for example proliferative vitreoretinopathy (PVR) and risk of PVR in the lower retina. Persistent or complicated macular holes can often be closed with heavy oil but in exchange higher rates of emulsification and cataracts are to be expected. Heavy silicone oils should not remain in the eye for longer than approximately 2 months, therefore, severe ocular trauma and ocular hypotension are not suitable indications. Initial technical difficulties to remove sticky (rare) oil from the retina have now been overcome by using liquid perfluorocarbons.

zum Artikel

Li W et al.:

CLINICAL RESULTS OF DENSIRON 68 INTRAOCULAR TAMPONADE FOR COMPLICATED RETINAL DETACHMENT.

Ophthalmologica 2010; 224(6): 354-60.

ABSTRACT
To assess the success rates and complications of Densiron 68 intraocular tamponade in the management of complicated retinal detachment (RD) with proliferative vitreoretinopathy (PVR). Methods:Twenty-one eyes of 20 patients with complicated RD and PVR were included in this prospective study. Vitreoretinal surgery with Densiron 68 intraocular tamponade was performed in all patients. Results:The success rate with 1 operation using Densiron 68 was 85.7%, and with further surgery 90.5%. Visual acuity improved from a mean logMAR of 2.25 (SD 0.73) to 1.19 (SD 0.88), p = 0.0001. There was little evidence of dispersion and excessive inflammation. Conclusion:According to the results of this study, vitreoretinal surgery with temporary Densiron 68 intraocular tamponade appears to increase the anatomical success and improve visual acuity, while giving rise to minimal complications, in selected cases of complicated RD and PVR..

zum Artikel

Lappas A et al.:

USE OF HEAVY SILICONE OIL (DENSIRON-68) IN THE TREATMENT OF PERSISTENT MACULAR HOLES.

Acta Ophthalmol 2009; 87(8): 866-70.

PURPOSE:
In this retrospective case series, we studied the effect of 'heavy' silicone oil on persisting macular holes. Patients with macular holes that failed to close after conventional macular hole surgery were retreated with the longterm internal tamponade Densiron-68.

METHODS:
Twelve patients with primary macular holes that persisted after pars plana vitrectomy, peeling of the internal limiting membrane and internal gas tamponade with SF6 (sulphur hexafluoride) were retreated with heavy silicone oil, Densiron-68, in the University Eye Hospital, Cologne. After 1.5-4 months the Densiron-68 was removed. Best corrected visual acuity (VA), slit-lamp examination, binocular fundus examination and optical coherence tomography (OCT) were used for evaluation pre- and postoperatively. The follow-up period was 3-7 months.

RESULTS:
Preoperatively, all patients displayed full-thickness macular holes, with a mean size of 502.25 microm (+/- 129.39 microm). Postoperatively, 11 of 12 macular holes were closed. One patient experienced a reopening of the macular hole. Mean VA was 20/250 (1.07 +/- 0.22 logMAR) prior to treatment with Densiron-68 and 20/160 (0.84 +/- 0.24 logMAR) postoperatively. Visual acuity increased from baseline in nine patients and decreased in one.

CONCLUSIONS:
Retreatment of persisting macular holes with the heavy, longterm tamponade Densiron-68 resulted in anatomical closure of the hole in 11 of 12 cases. This result was accompanied by a functional improvement in VA in nine of 12 patients.

zum Artikel

Rizzo S et al.:

HEAVY SILICONE OIL (DENSIRON-68) FOR THE TREATMENT OF PERSISTENT MACULAR HOLES: DENSIRON-68 ENDOTAMPONADE FOR PERSISTENT MACULAR HOLES.

Graefes Arch Clin Exp Ophthalmol 2009; 247(11): 1471-6.

PURPOSE:
To evaluate the efficacy and safety of the use of Densiron-68 as intraocular endotamponade for the treatment of persisting macular holes (persistent MHs).

METHODS:
Retrospective interventional case study on 23 consecutive eyes showing persistent MHs after unsuccessful primary surgery that underwent retreatment with pars plana vitrectomy and Densiron-68 filling. The main outcome measures were: anatomic closure evaluated with optical coherence tomography (OCT), final best-corrected visual acuity (BCVA), and postoperative complications.

RESULTS:
A total of 23 patients (52-88 years) were studied. Pre-operative OCT showed full-thickness MH (mean size 560 microm) in all patients. Densiron-68 was left in situ for 1.5-3 months. Final follow-up time was 12 months after the last surgery. Postoperative OCT showed the complete closure of the PMH in 20 of 23 eyes. Pre-operative BCVA ranged from 20/200 to 20/630 (1.50-1.00 logMAR, mean 1.14). Final postoperative BCVA ranged from 20/30 to 20/400 (0.18-1.30 logMAR, mean. 0.61). Nineteen eyes (82%) showed a significant increase in visual acuity by at least three lines: 11 (47%) patients gained at least four lines. Three eyes remained unchanged (13%). One case deteriorated by two lines (4%). No major complications were recorded.

CONCLUSIONS:
Retreatment with Densiron-68 filling was safe and achieved encouraging anatomic and functional results.

zum Artikel

Auriol S et al.:

EFFICACY AND SAFETY OF HEAVY SILICONE OIL DENSIRON 68 IN THE TREATMENT OF COMPLICATED RETINAL DETACHMENT WITH LARGE INFERIOR RETINECTOMY.

Graefes Arch Clin Exp Ophthalmol 2008; 246(10): 1383-9.

PURPOSE:
To assess the efficacy and safety of a heavy silicone oil (Densiron 68 a mixture of perfluorohexyloctane (F(6)H(8)) with silicone oil as temporary internal tamponade in selected retinal detachments treated with large inferior retinectomy.

METHODS:
Complicated retinal detachments with severe posterior and anterior proliferative vitreoretinopathy (PVR) were included in this study. In all cases, a large inferior retinectomy involving the inferior quadrants was performed. Densiron 68 was injected at the end of surgery after perfluorocarbon injection. A minimum follow-up of 6 months was required in order to be included in this retrospective study.

RESULTS:
Twenty-seven patients were operated on with a mean follow-up of 57.5 weeks. Twenty-three patients presented a posterior PVR > CP6 and 26 patients an anterior PVR > CA5. Heavy silicone oil was removed in 19 patients after a mean follow-up of 14 weeks. At the 4-week follow-up visit, only one retinectomy was reopened by a recurrent inferior retinal detachment with PVR CP3. Finally, anatomical success was achieved in 25 of the 27 patients (92.5%) after Densiron 68 removal at the last follow-up. The main adverse effect was inflammatory reaction with fibrin accumulation in the anterior chamber (40.7%).

CONCLUSION:
Densiron 68 appeared to be an efficient endotamponade agent in selected retinal detachments treated with large inferior retinectomy. It avoids fluid accumulation under the inferior retina and seems to limit the rate of inferior retinectomy reopening.

zum Artikel

Romano MR et al.:

PRIMARY VITRECTOMY WITH DENSIRON-68 FOR RHEGMATOGENOUS RETINAL DETACHMENT.

Graefes Arch Clin Exp Ophthalmol 2008; 246(11): 1541-6.

BACKGROUND:
To report a retrospective non-comparative interventional study on the effectiveness and ocular tolerance of a heavy silicone oil tamponade (HSO, Densiron-68) for primary inferior rhegmatogenous retinal detachment (RRD).

METHODS:
Forty-one eyes of 41 consecutive patients were recruited between January 2004 and August 2006. Primary vitrectomy with Densiron-68, a heavy silicone oil, was used in all cases. Inclusion criteria were primary RRD with at least one retinal break between 4 and 8 clock hours. The study protocol consisted of a minimum of eight clinic visits: baseline, surgery, 1 week, 1 month and 3 months after the initial surgery; removal of oil and 1 week, 1 month and 3 months postoperatively. The primary endpoint was anatomical re-attachment of the retina. Cases were judged successful when there was reattachment of the retina in the absence of any tamponade agent. The secondary endpoint was to record the visual function and any complications arising from the surgery. Out of 41 patients initially included in the study, 33 completed all follow-up visits.

RESULTS:
Anatomical success was achieved in 91% of cases (30 out of 33) with one retinal operation, and rose to 94% (31 out of 33) with additional surgery. Mean visual acuity improved from logMAR 1.19 (SD 0.9) to 0.5 (SD 0.51, p = 0.001). No significant ocular hypertension, clinically significant emulsification of the tamponade or inflammation developed during follow-up.

CONCLUSION:
With Densiron-68, high anatomical and functional success rates can be achieved with primary vitrectomy for RRD and predominantly inferior pathology.

zum Artikel