|Year : 2017 | Volume
| Issue : 1 | Page : 9-14
Densiron-68 in the treatment of retinal detachment associated with inferior proliferative vitreoretinopathy or caused by lower or posterior breaks
Ayman Ahmed Alkawas, Elsadek Abdelaziz Maaly, Basem Mohammed Ibrahim, Mukhtar Amin Al-Humiari
Department of Ophthalmology, Zagazig University, Zagazig, Egypt
|Date of Web Publication||20-Apr-2017|
Mukhtar Amin Al-Humiari
Department of Ophthalmology, Zagazig University, P. O. Box 53, Zagazig 44511
Source of Support: None, Conflict of Interest: None
Aim: The aim of this study is to demonstrate the efficacy and complications of heavy silicone oil (Densiron-68®) in the treatment of retinal detachment (RD) with inferior, posterior breaks, or associated with proliferative vitreoretinopathy (PVR). Materials and Methods: A prospective interventional noncomparative case series study of 25 eyes of 25 patients. Inclusion criteria were patients having RD arising from PVR, posterior breaks or inferior retinal breaks between 4 and 8 o'clock hours. Primary vitrectomy followed by Densiron-68 injection was performed for each patient. The study protocol involved at least 8 visits: 1st day, 1, 2, 3 weeks 1, 2, 3, and 6 months. Densiron-68 removal was performed after 2–3 months. The assessment of retinal attachment, visual acuity (VA), and complications were recorded. Results: Final anatomical success was 84% (21 of 25) cases which increased to 92% with second intervention. Mean final VA improved from mean logarithm of minimum angle of resolution of 1.89± (0.66) preoperatively to 1.094± (0.29) postoperatively. The most common complications were cataract in 60% of phakic eyes, and early emulsification in 32%. Conclusion: Densiron-68 could be used to support the lower retina in cases with RD associated with PVR, inferior, or posterior breaks. It gives a better tamponade to the inferior retina in the in the supine or upright positioning of the patient with high anatomical success rate.
Keywords: Densiron-68, heavy silicone tamponades, proliferative vitreoretinopathy, retinal detachment
|How to cite this article:|
Alkawas AA, Maaly EA, Ibrahim BM, Al-Humiari MA. Densiron-68 in the treatment of retinal detachment associated with inferior proliferative vitreoretinopathy or caused by lower or posterior breaks. Egypt Retina J 2017;4:9-14
|How to cite this URL:|
Alkawas AA, Maaly EA, Ibrahim BM, Al-Humiari MA. Densiron-68 in the treatment of retinal detachment associated with inferior proliferative vitreoretinopathy or caused by lower or posterior breaks. Egypt Retina J [serial online] 2017 [cited 2018 Feb 23];4:9-14. Available from: http://www.egyptretinaj.com/text.asp?2017/4/1/9/204839
| Introduction|| |
For years, the mostly widely used endotamponade products are gas (SF6 and C3F8) or conventional silicone oil. However, these products have certain limitations regarding their efficacy in tamponading the inferior retina in the usual supine or upright postoperative positioning of the patient. These are observed in eyes with inferior retinal detachment (RD) caused by inferior breaks presented anywhere between 4 and 8 o'clock hours. Furthermore, the use of lighter than water endotamponades increases the chance of proliferative vitreoretinopathy (PVR) due to the accumulation of the growth factors in the inferior and posterior pole of the retina.
This led to the development of heavy silicone oils, a new group of tamponade agents with a specific gravity greater than that of water to support the inferior retina. These substances should provide adequate tamponading to the inferior retina. In addition, they must develop high surface tension with water to occlude tears, preventing entrance of water and vitreoretinal proliferation to the interface between the subretinal and preretinal spaces. Furthermore, its higher gravity will support the lower fundus periphery in the upright and supine position.
Several heavy endotamponade silicone were introduced in the early 1990s as perfluorohexyloctane (F6H8), and fluorosilicone oil [Video 1], and in the early 2000s as semiflurinated alkanes and their oligomers as (OL62HV), and perfluorohexylethan (O62)., However because of their side effects, it led to their limited use. These disadvantages included retinal toxicity if not removed in situ, the high rate of early emulsification and precipitates formation. Double filling with F6H8 and silicone oil has been used to provide support for both the upper and lower retina. However, they merged together and gave unsatisfactory tamponade effect.
The most recent generation of heavy silicone oils gave promising results.,,,,, One of these newly modified heavy silicone oil is Densiron. Densiron 68®, comprises a mixture of 30.5% F6H8 and 69.5% polydimethylsiloxane (silicone oil). Densiron ® 68 has been designed to take advantage of the high specific gravity of F6H8 and the high viscosity of silicone oil. The solution has a density of 1.06 (that is higher than water) and a viscosity of 1400 mPas (significantly higher than F6H8).,
In this study, we are going to demonstrate the anatomical and functional results of using Densiron 68 as an endotamponade in certain complicated RD patients as well as demonstrating its complications.
| Materials and Methods|| |
This work was carried out in the Ophthalmology Department, Zagazig University Hospitals between 2012 and 2016. It is a prospective interventional noncomparative case series study of 25 eyes of 25 patients.
Consent was obtained from all the patients and a brief description of the operation was explained to them. The work was IRP approved.
All patients included were either having RD caused by inferior, posterior breaks or complicated with vitreoretinopathy (PVR).
Preoperative evaluation included a detailed history, best corrected visual acuity (BCVA) using Snellen chart, intraocular pressure (IOP) measurement using Goldmann applanation tonometry, anterior segment evaluation with slit lamp, and indirect ophthalmoscopy to examine the fundus. The PVR grading was based on the updated classification of Machemer et al. 1991. Postoperative follow up was done at the 1st day, 1st week, 2nd week, 3rd week, 1st month, 2nd month, 3rd month, and 6th month postoperatively. In each visit, a brief history was taken, BCVA, and IOP were recorded, anterior segment, and funds examination were performed.
Densiron removal was planned to be done within 2–3 months from the initial procedure.
All statistical calculations were performed using SPSS version 16.0.1 (Densiron-68. FLUORON GmbH, Germany).
All surgeries were performed under general anesthesia. Standard 20-gauge 3-port or 23-gauge 3-port pars plana vitrectomy (PPV) was performed by the same surgeon (A.A.). Devices used were either DORC Associate ® 2500 from Dutch Ophthalmic Company (Zuidland, The Netherlands) or the OS3® 3000 from Oertli Instruments AG, (Berneck, Switzerland).
Core vitrectomy followed by peripheral vitrectomy was done.
Vitrectomy was completed up to the anterior vitreous base. All tractions were released by peeling retinal membranes. If traction still persisted, which was noticed in three cases of Grade C PVR, surgical retinectomy was done to release the traction. In twenty eyes, endodrainage was made inferonasal to the optic disc and subretinal fluid was drained by fluid-air exchange then air-Densrion exchange. In two eyes with giant retinal tears, perfluorocarbon liquid (PFCL) was used to support the retina and to drain subretinal fluid. PFCL was then exchanged with air before Densiron injection. The last three eyes that had relaxing retinotomy had subretinal fluid drainage through the retinectomies by direct Densiron injection. The heavy tamponade effect of Densiron was used to flatten the retina and to drain subretinal fluid. Three rows of endolaser photocoagulation were applied around the areas of retinectomy, endodrainage site, around breaks, and in eight eyes, it was done circumferentially around the vitreous base.
Densiron-68 was infused to the vitreous cavity using an 18-gauge cannula aiming for complete fill of the cavity.
Densiron-68 was removed after 2–3 months according to the retinal stability and the presence of complications. Densiron was extracted by active suction using 18-gauge silicone cannula directed toward the posterior pole under direct illumination. Aspiration rate of 600 mmHg is needed for complete aspiration of Densiron. If after Densiron extraction detachment occurred, a second operation was done. In cases presented with cataract at the time of Densiron removal, combined phacoemulsification, and Densiron removal was performed.
| Results|| |
Twenty-five eyes of 25 patients were included from the study. There were 18 males and 7 females with an average age of 47 (±12) years ranging from 10 to 64 years old. At the time of preoperative examination, 20 eyes were phakic and 5 eyes were pseudophakic. Mean preoperative visual acuity (VA) was 1.89 (±0.66) logarithm of minimum angle of resolution (log MAR). IOP ranged from 8 to 18 mmHg with an average of 11.6 mmHg.
The duration of RD ranged from 3 weeks to 3 months. The extent of RD involved one quadrant in 2 eyes (8%), two quadrants in 12 eyes (48%), three quadrants in 5 eyes (20%), and total RD in 6 eyes (24%). Macular detachment was noticed in 20 eyes (80%). PVR Grade C was present in 17 eyes (68%), and PVR Grade B in 8 eyes (32%). Epimacular membrane was not detected in any eyes. Ten eyes had previous RD operations. Four of which had buckle, three had PPV using silicone oil endotamponade, and three had both buckle and vitrectomy. Preoperative retinal assessment is summarized in [Table 1].
Mean follow up duration after primary operation was 28 (±4) weeks (range 24–32 weeks).
The anatomical success rate can be divided to primary anatomical success, with Densiron in situ, and final anatomical success, after Densiron removal. With Densiron in situ, the success rate was 92% (23 eyes). Two eyes developed RD. Thefirst eye (patients number 6) developed superior giant break 2 months after the operation. The other eye (patients number 17) had localized lower detachment with macular pucker.
At the time of Densiron removal, two other eyes (patient 3 and 20) developed RD. Therefore the anatomical success rate after Densiron removal became 84%. Three patients (3, 6 and 20) had another vitrectomy operation and silicone oil tamponade. However, patient 17 had lower detachment with extensive submacular PVR and refused further intervention.
At 6 months duration, patients 6 and 20 were successfully attached with conventional silicone oil. Patients 3 developed peripheral lower RD not extending to posterior pole and no further intervention was done. Therefore, at 6 months 23 eyes had attached retina with a success rate of 92%. Anatomical outcome during the study is summarized in [Table 2].
Densiron removal was done on an average duration of 2.5 months (range 2–3.5 months) after its injection [Figure 1].
Preoperative and postoperative visual acuities are summarized in [Table 2]. The final mean BCVA showed improvement from 1.89 (±0.66) log MAR preoperatively to 1.094 (±0.29) log MAR at 6 months after the initial surgery. This VA improvement was statistically significant (t = 6.18, P = 0.0001, 95% confidence interval). VA improved more than two lines in 18 eyes (72%). The improvement of two lines or less was seen in 4 eyes (16%) However, 3 eyes (12%) did not show any improvement in vision. Pre- and post-operative log MAR visual acuities are shown in [Figure 2]. A factor that could affect the VA results is previous retinal operations. Our results showed VA improvement of eyes without previous RD operation from a mean of 2.22 (±0.62) log MAR preoperatively to a mean of 1.07 (±0.26) postoperatively. While those with previous RD operations showed a mean VA improvement from 1.41 (±0.33) log MAR preoperatively to 1.12 (±0.35) log MAR postoperatively. Both groups showed statistically significant improvement of VA (t = 7.34, P = 0.00004, 95% confidence interval) and (t = 3.569, P = 0.006, 95% confidence interval), respectively.
|Figure 2: Preoperative and final postoperative visual acuity of all 25 eyes with logarithm of minimum angle of resolution.|
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[Table 3] summarizes the complications during Densiron endotamponade and after its removal. The most frequent complication was cataract occurring in 60% of phakic eyes. Cataract operation was performed to all of these eyes successfully at time of Densiron removal. The second most common complication was the development of emulsification. This was noted in 8 eyes (32%) which usually developed by the end of the 2nd month after the primary surgery. Only three cases (12%) developed increase in IOP. Topical antiglaucoma eye drops were able to decrease IOP. Epiretinal membranes was noted in two cases (8%) and inflammatory fibrinous reaction in the anterior chamber developed in 2 eyes (8%) that was resolved with topical steroids. Hypotony was recorded only in one eye (4%).
| Discussion|| |
It is still a challenge to maintain sufficient support to the inferior retina in cases of inferior RD associated either with inferior large breaks or complicated with PVR. Conventional silicone oil may be limited due to the absence of support to the inferior retina and as a result of accumulation of inflammatory materials inferiorly causing PVR formation. The success rate with conventional silicone oil tamponade in patients with rhegmatogenous RD with PVR ranged from 30% to 83%.[14-17]
In a study by Romano et al. in 2011, they compared vitrectomy using Densiron-68 and vitrectomy using buckle and gas injection for RD caused by inferior breaks and found similar high anatomical success rate in the two groups. However, they mentioned some drawbacks of scleral buckle which may, in our opinion, favors the use Densiron-68.
Therefore, with the increased trends to move away from scleral buckle, heavy liquids to tamponade the inferior retina have been developed. Some of the early heavy tamponade showed problems as retinal toxicity and early emulsification which limited their use, nevertheless new heavy liquid tamponade as Densiron-68 showed some promises.
In this study, a heavier than water Densiron-68 was used as an endotamponade for cases with complex inferior RD or inferior breaks. With Densiron in situ, two eyes developed detachment. One eye (patient 6) developed superior giant break. A possible explanation is incomplete filling of the vitreous leaving the superior retina less supported. The other eye developed PVR with submacular membrane (patient 17).
Densiron removal was planned after 3 months. However, due to early emulsification and cataract formation, Densiron was removed before 3 months in 15 eyes (60%).
After the removal of Densiron, two other eyes developed RD (patient 3 and 20). Three of the detached eyes (patient 3, 6 and 20) required re-intervention and conventional silicone oil injection. Two patients (6 and 20) were successfully attached. Patient 3 had peripheral lower RD not threatening the macula and was left with no further intervention. Patient 17, however, had extensive macular and submacular membrane and refused further intervention.
Our final results at Densrion removal showed anatomical success rate of 82% (21 eyes). However, the success rate increased to 92% (23 eyes) at 6 months duration after further intervention [Table 2]. Comparable anatomical results to our work was reported by Sandner and Engelmann 89%, Herbrig et al., 87%, Lim and Vote, 86% and Li et al., 85%. Other case series reported variable results ranging from 33% to 92%. Auriol et al., investigated the efficacy of Densiron in the treatment of complicated RD with large retinectomy and reported a higher success rate of 92%. Another case series by Romano et al., on the efficacy and safety of Densiron in primary inferior RD showed a higher anatomical success rate of 91%. However, Sandner et al., who were thefirst to investigate the efficacy of Densiron as a primary intraocular tamponade, showed disappointing success rate (33%). This could be explained by the type of patients involved, most have either advanced anterior PVR or high myopia with posterior staphyloma (in which silicone oil tamponade provides insufficient pressure effect at the posterior pole), and relaxing retinectomy was not done.
Regarding VA results after 6 months follow up, VA improved in our study from a mean preoperative VA of 1.89 log MAR ± 0.66 standard deviation (SD) to 1.094 log MAR ± 0.29 SD. Comparable results was reported by Duan et al., (from 2.41 to 1.16). In a study by Rizzo et al., who worked on eyes with macular hole, they showed better final VA improvement (from 1.14 to 0.61). Levasseur et al., worked a case series to evaluate the effectiveness of Densiron with primary inferior RD. They reported VA improvement (from 1.29 ± 0.61 to 0.87 ± 0.67). Their better final VA could be attributed to the selected cases in which all eyes had primary inferior RD. Other studies showed variable results of final VA results as with Auriol et al., (from 1.55 ± 0.21 to 1.34 ± 0.39), or Macías-Murelaga et al., (from 1.45 ± 0.5 to 1.16 ± 0.4).
Eyes that had previous RD operation and those without RD operation showed statistically significant improvement of VA. However, primary vitrectomized eyes showed better visual outcome from a mean of 2.2 (±0.62) log MAR preoperatively to a mean of 1.06 (±0.27) postoperatively compared to the previously RD operated eyes who had raised VA from 1.39 (±0.34) log MAR preoperatively to 1.09 (±0.39) log MAR postoperatively.
Adverse effects of Densiron-68 were similar to those seen with conventional silicone. The most common complication was cataract formation. In our study, lens opacity progressed in 12 eyes (60%) of the phakic eyes. Other case series and multicenter trials using Densiron showed cataract progression in all phakic eyes.,,, Only a few series showed lower incidence of cataract progression. This could be attributed to early Densiron removal. Li et al., evaluated the complications associated with the use of Densiron as an endotamponade. They reported cataract progression in 25% of phakic eyes. It has been postulated that the risks of cataract progression are caused by certain factors including the grade of lens opacity at the time of operation, any type of lens touch during vitrectomy, the age of the patient, and early emulsification which causes increased cellular infiltration triggered by foreign body effect to emulsified Densiron. Duan et al., mentioned other factors that may contribute to lens opacification including direct touch of Densiron-68 or emulsified Densiron-68 to the lens, the prolonged operation in complicated RD, and the low viscosity of Densiron-68 compared to the conventional silicone oil, which allows Densiron-68 and the emulsified droplets to cause opacification of the posterior lens capsule.
In our study, glaucoma developed in 3 eyes (12%). Similar results were obtained by earlier reports., Elevated IOP was controlled with topical antiglaucoma eye drops.
Dispersion and emulsification occurred in 8 eyes (32%) in this study. This percentage was comparable to Duan et al. (42.4%). However, this percentage is higher than other studies (11%, 15%, 16.7%, 18.5, 20%). Possible explanation of early emulsification is the low viscosity of Densiron-68 (1400 cSt.) compared to the higher viscosity of other silicone oil. Another reason was suggested by Dresp and Menz  who mentioned that impurities and contamination derived from heavy liquids used intraoperatively or remnants of silicone detergent of the vitreoretinal instruments led to emulsification. However, Duan et al., pointed to change in the environment as another role to early emulsification as change in pressure, temperature, and ocular movement [Figure 3].
In the present study, epiretinal membrane formation were recorded in 2 eyes (8%) which can be explained as a gliotic response of Muller cells and macrophage activation. Hypotony was seen in one patient and a possible explanation is the complex PVR before operation, membrane formation over the ciliary body and his young age. In fact, such changes can be seen following unsuccessful surgery with conventional silicone oil and similar results were reported by previous reports.,,
Inflammatory reaction in the anterior chamber in the form of fibrinous exudate occurred in two eyes (8%) which were managed with topical steroids and mydriatic. Other studies reported that the incidence of intraocular inflammations ranged from 7.1% to 13.1%.,, Predisposing factors included multiple surgeries, excessive endolaser photocoagulation, and large retinotomy.
Our study had some limitations being noncomparative, and represents only one surgeon's initial experience. The number of the cases included in this study is limited, further studies with large series are needed.
| Conclusion|| |
It seems that Densiron-68 can be a used in selected patients giving a better tamponade and support to the inferior retina, especially with complicated RD associated with lower PVR. It also could be used in RD associated with inferior breaks instead of scleral buckle. Furthermore, the postoperative supine or upright positioning is more satisfying for the patients. The results suggested that Densrion-68 achieves high anatomical reattachment, but functional results are less satisfying. Regarding complications, special attention must be paid to the adverse reactions, especially inflammatory reactions and dispersion.
Financial support and sponsorship
The study was financially supported by the Department of Ophthalmology, Zagazig University Hospitals.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]