The Argus II Retinal Prosthesis: 12-month outcomes from a single-study center.

PURPOSE: To study the anatomic and functional outcomes of Argus II Retinal Prosthesis System implantation in patients with retinitis pigmentosa. DESIGN: Interventional case series. METHODS: The study population included 6 patients with visual acuity no better than light perception. After the Argus II Retinal Prosthesis System was implanted, complications and anatomic and functional results were studied. The main outcome measures were mobility, square localization, direction of motion, grating visual acuity, and Goldmann visual field, all of which were assessed. Optical coherence tomography was performed. RESULTS: Implantation of the Argus II Retinal Prosthesis System was safely performed in all patients. One patient experienced postoperative elevation in intraocular pressure, which was controlled medically. In 1 patient, moderate detachment of the choroid occurred postoperatively, and it resolved spontaneously. One patient withdrew from the study. Wound dehiscence, endophthalmitis or retinal detachment was not observed. All patients were able to locate a bright light on the ceiling and a dark line on the floor after the surgery. Performance in square localization tests improved in 4 patients, and direction of motion improved in 3 patients. One patient achieved grating visual acuity. Goldmann visual field test results improved in all patients. CONCLUSIONS: The patients showed improvement in visual tasks after the surgery, and the device was well tolerated and functional over a 1-year follow-up period. A rigorous patient-selection process is necessary to maximize patient compliance with the rigorous follow-up testing schedule. Both patients and medical staff should be prepared for a lengthy, arduous rehabilitation process.

Optic disc pit maculopathy: the value of small-gauge vitrectomy, peeling, laser treatment, and gas tamponade.

PURPOSE: To report the outcome of 10 patients with optic pit maculopathy (OPM) and evaluate the role of small-gauge vitrectomy, gas endotamponade, and additional laser photocoagulation treatment. METHODS: We retrospectively investigated 10 patients who underwent small-gauge, sutureless vitrectomy for OPM, detachment of the posterior hyaloid, internal limiting membrane (ILM) peeling, endolaser photocoagulation on the temporal margin of the optic disc, and gas tamponade. Preoperative and postoperative best-corrected visual acuity (BCVA) was recorded and optical coherence tomography (OCT) imaging was performed. RESULTS: Seven out of 10 patients gained at least 2 lines of vision; 2 patients gained 1 line of vision. Visual improvement occurred more than 3 months after surgery. One myopic patient developed a macular hole postoperatively, resulting in a poor functional result even though complete retinal attachment was achieved. The functional outcome did not always correlate well with the OCT imaging, in which complete retinal reattachment was observed in 5 out of 10 eyes. CONCLUSIONS: The therapeutic approach should include both small-gauge vitrectomy and ILM peeling to relieve vitreoretinal traction, as well as laser photocoagulation of the temporal margin of the optic disc in order to prevent vitreous fluid from entering the subretinal/intraretinal space. In addition, the patients should be told that visual recovery can take a long time.

Colored perfluorocarbon liquids as novel intraoperative tools.

BACKGROUND: Perfluorocarbon liquids (PFCLs) are used as intraoperative tools to stabilize the retina during vitreoretinal surgeries. Their use would be much facilitated if PFCLs were colored and not transparent. We describe the development of a colored PFCL for vitreoretinal surgeries. METHODS: Perfluorohexyloctan (F6H8) was colored by adding a blue, biocompatible anthraquinone dye, and then mixed with perfluorodecalin (PFD) or perfluorooctane (PFO) at different volume percentages. The thus-obtained colored PFCLs were incubated with lens, lens capsule, vitreous body, and retina of enucleated porcine eyes for staining purpose and analyzed microscopically. To analyze possible interactions between colored PFCLs and silicone oil, colored PFCLs were exchanged to BSS and silicone oil respectively in enucleated pig eyes. RESULTS: By mixing different volume% of colored F6H8 with perfluorodecalin (PFD) or perfluorooctane (PFO), colored PFCLs of different density and staining intensity were obtained. Cornea, lens, lens capsule, vitreous, and retina showed no signs of staining after incubation with colored PFCLs for 10 min. Colored PFCLs were transparent despite intense coloring, thus allowing a clear visibility of the underlying tissue. Immediately after instillation of silicone oil, the colored PFCL bubble was well-defined, and colored PFCL was easily aspirated. After 5 minutes reaction time, considerable diffusion of the dye from the PFCL bubble into the silicone oil was observed. CONCLUSIONS: The staining intensity can be varied according to the volume% of the colored F6H8 phase. Colored PFCL is clearly visible when installed in the vitreous cavity of a pig eye, and can easily be removed. It does not stain the intraocular tissues in pig eyes. Colored PFCL can be exchanged with silicone oil. But a time-dependent diffusion of the dye into the silicone oil was observed in pig eyes, indicating that the contact should be limited.

Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases.

AIM: To compare a standard 25-gauge vitrectomy system with a new ultrahigh-speed (UHS) 25-gauge system with duty cycle control for pars plana vitrectomy. METHODS: In this prospective, controlled clinical trial, 120 patients (divided into 2 groups of 60 patients) underwent a 3-port pars plana vitrectomy for the treatment of epiretinal membranes, macular holes, retinal detachment, and complications of diabetic retinopathy. Evaluations were performed preoperatively, intraoperatively, on the first 3 postoperative days, and at 1 week, 1 month, and 3 months. Main outcome measures were vitrectomy time, induction of posterior vitreous detachment, and intra- and postoperative complications. Vitrectomy time included retinal manipulation, but did not include wound opening and closure. RESULTS: The duration of surgery was significantly different between the groups. Patients in the new UHS 25-gauge group had a significantly shorter duration of vitrectomy time (P < 0.0001). Mean overall vitrectomy time was 1,583.7 ± 875.4 seconds (26 minutes) in the standard 25-gauge group and 1,106.3 ± 575.9 seconds (18 minutes) in the UHS 25-gauge group. Twenty-nine patients (48.3%) in the standard group and 27 patients (45.0%) in the UHS group experienced induction of posterior vitreous detachment. Thirteen patients (21.7%) in the standard 25-gauge group and 1 patient (1.7%) in the new UHS group had intraoperative iatrogenic retinal breaks. CONCLUSION: The new-generation UHS 25-gauge system may provide a new paradigm of high-flow, smaller-diameter instrumentation, thus increasing the efficiency of the small-gauge technique and the safety of the surgery.

Surgical results of heavy silicone oil HWS-45 3000 as internal tamponade for inferior retinal detachment with PVR: a pilot study.

PURPOSE: To report the results of a prospective pilot study using a new heavy agent, HWS-45 3000, as endotamponade in complicated inferior retinal detachment. METHODS: Ten consecutive patients satisfying the enrolment criteria were studied. Inclusion criteria was the presence of inferior retinal detachment complicated by PVR grade C2 or more (according to Retina Society classification) or retinal detachment due to penetrating ocular trauma or giant retinal tears. Heavy silicone oil was injected at the end of surgery after peeling of retinal membranes and/or retinotomy. Follow-up protocol visits were scheduled at 1 day, 1 week, 1 month, and 2 months after the initial surgery and 1 week, 1 month and 6 months after HWS-45 3000 removal surgery. Oil removal was planned after about 2 months from the main surgery. RESULTS: At the 1-month protocol visit, eight eyes presented retinal reattachment and two eyes presented a retinal detachment not involving the posterior pole. Visual acuity ranged from 2.2 logMAR to 1.0 (mean: 1.45, SD: 0.53). Oil removal surgery was scheduled about 60 days postoperatively. All eyes required additional endolaser treatment during removal surgery, and four eyes epiretinal membrane peeling. In two eyes that presented retinal detachment not involving the posterior pole, tamponading with 5700 cSt silicone oil was necessary. At 3- and 6-month protocol visits, all patients presented retina reattached; two eyes had silicone oil as internal tamponade. CONCLUSION: From our first results, HWS-45 3000 appears to be a well-tolerated heavy oil suitable for the treatment of complicated inferior retinal detachment.

Incidence of retinal detachment after small-incision, sutureless pars plana vitrectomy compared with conventional 20-gauge vitrectomy in macular hole and epiretinal membrane surgery.

PURPOSE: The purpose of this study was to evaluate the incidence of retinal detachment (RD) after a small-incision, sutureless vitrectomy compared with conventional 20-gauge vitrectomy in macular hole and epiretinal membrane surgery and to investigate the clinical features and possible causative agents. METHODS: The authors performed a computerized database analysis to retrospectively identify all patients who underwent vitrectomy at our institution between March 2001 and March 2009 for epiretinal membrane and macular hole. The authors further investigated the clinical features of patients who showed RD within 6 months postoperatively in the study eye. The incidence rate and clinical features of the affected eyes were analyzed. RESULTS: During the study period, 2,432 vitrectomies were performed for epiretinal membrane and macular hole. The incidence of RD was 1.7% (31 of 1,862) after sutureless 25- or 23-gauge vitrectomy and 1.2% (7 of 570) after conventional 20-gauge vitrectomy. The difference was not statistically significant. Moreover, the difference between 25-gauge surgery (28 of 1,580) and 23-gauge surgery (3 of 282) was not statistically significant. In 9 of 38 cases (24%), the RD was probably attributable to the underlying pathology (e.g., an unclosed macular hole and reopening of preexisting retinal tears). Twenty-one eyes (76%) presented new retinal tears that were not related to the sclerotomies in both groups. CONCLUSION: The incidence of RD after macular surgery is not increased in small-gauge, sutureless vitrectomy compared with the standard 20-gauge procedure. In most cases, the RD is not caused by the surgical technique itself but caused by new retinal breaks.

Retinal detachment after small-incision, sutureless pars plana vitrectomy: possible causative agents.

BACKGROUND AND PURPOSE: To identify possible agents causing retinal detachment following small-incision, sutureless vitrectomy. METHODS: Computer-based, retrospective analysis to identify all patients who had undergone small-incision sutureless vitrectomy and presented retinal detachment (RD) in the study eye within 6 months postoperatively. The clinical charts of these patients were reviewed. RESULTS: The investigation involved 2,598 small-incision, sutureless vitrectomies. Thirty-seven eyes presented subsequent RD. Indications for sutureless vitrectomy were idiopathic epiretinal membrane (n = 15), idiopathic macular hole (n = 15), recurrent macular hole (n = 1), rhegmatogenous retinal detachment (n = 5) and vitreous haemorrhage due to proliferative diabetic retinopathy (PDR) (n = 1). The median time between sutureless vitrectomy and RD presentation was 51 days (range 11-173 days); mean 59 days (SD 46.5). In 14 eyes (38%), the RD was most likely due to the underlying pathology (e.g., unclosed macular hole, reopening of pre-existing retinal tears, worsening of PDR). Twenty-three eyes (62%) presented with new retinal tears that were not in the proximity of the sclerotomies. CONCLUSION: In most cases, the RD was not caused by the sutureless technique itself, but was most likely due to the underlying pathology, or due to new retinal tears that were not in the proximity of the sclerotomies.

A new heavy silicone oil (HWS 46-3000) used as a prolonged internal tamponade agent in complicated vitreoretinal surgery: a pilot study.

PURPOSE: To report the results of a prospective pilot study using a new heavy agent, HWS 46-3000, as long-term endotamponade in complicated retinal detachment. METHODS: Thirty-two consecutive patients were enrolled in the study. Indications for enrollment included retinal detachment with proliferative vitreoretinopathy arising from inferior or posterior tears. The patients underwent pars plana vitrectomy, membrane peeling, and HWS 46-3000 filling. Follow-up examinations were scheduled at 1 day to 7 days and 1 month to 3 months after initial surgery and 7 days and 1 month to 6 months after endotamponade removal. RESULTS: At baseline examination, mean best-corrected Snellen visual acuity was 2.44 logarithm of the minimal angle of resolution (logMAR). HWS 46-3000 was removed after 45 days to 96 days. Initial retinal reattachment was achieved in all eyes. HWS 46-3000 endotamponade was associated with a success rate of 84.6% with a single surgery and an overall success rate of 100% at 6 months with the second operation and conventional silicone oil endotamponade. At 6 months, mean best-corrected visual acuity was +1.09 logMAR (P < 0.0001). Complications were posterior subcapsular cataract formation (100%), membrane formation (3 eyes, 9%), and increased intraocular pressure (1 eye). Emulsification and intraocular inflammation were not observed. CONCLUSION: HWS 46-3000 was well tolerated, effective in the inferior quadrants with a low incidence of membrane development. The main complication was the high rate of tamponade-related cataract formation.

Sutureless 25-gauge vitrectomy for idiopathic macular hole repair.

BACKGROUND: We investigated the feasibility and safety of a 25-gauge, transconjunctival sutureless vitrectomy system for macular hole repair. METHODS: Eighty-four eyes of 77 consecutive patients with idiopathic macular hole were operated on using a transconjunctival sutureless 25-gauge vitrectomy system. A complete vitrectomy was performed using triamcinolone acetonide to visualize the vitreous gel and to remove the posterior vitreous cortex. The macular hole was covered with autologous whole blood, and the internal limiting membrane (ILM) was stained with indocyanine green. The ILM was peeled and a fluid-air exchange performed. The globe was filled with gas, and the patient was kept in a prone position for 1 week. Surgery-related complications, macular hole closure on optical coherence tomography (OCT) and visual outcome were evaluated. RESULTS: No intra- or postoperative complications were recorded. It was noted in particular that sclerotomies did not require sutures. No postoperative hypotony or endophthalmitis was observed. OCT showed macular hole closure in 93% of the cases. The median preoperative best-corrected visual acuity was 20/200 and improved significantly (p<0.05) to a median best-corrected visual acuity of 20/67 (median follow-up 6.5 months). CONCLUSION: A 25-gauge transconjunctival sutureless vitrectomy, visualization of the vitreous with triamcinolone acetonide, protection of the macular hole with autologous whole blood and staining of the ILM using indocyanine green are safe and efficient techniques for macular hole repair.

Successful treatment of persistent macular holes using "heavy silicone oil" as intraocular tamponade.

BACKGROUND: Silicone oil tamponade has been suggested in the treatment of persistent macular hole, but visual outcome is often poor. We describe two patients who underwent reoperation for persistent macular hole using "heavy silicone oil" (HSO) tamponade. METHODS: Two patients who underwent vitrectomy, removal of the posterior vitreous cortex, peeling of the internal limiting membrane, and long-acting gas tamponade had persistent macular hole 3 months after surgery. The patients underwent reoperation using an HSO (Oxane Hd, Bausch & Lomb) as internal tamponade. This tamponade did not require postoperative posturing and was removed after 3 months. Optical coherence tomography (OCT) was performed, and visual outcome was determined. RESULTS: OCT images showed that the HSO bubble conformed well with the retinal surface in the foveal region. Closure of the macular hole was achieved in both patients. Visual acuity increased from 20/100 to 20/40 in Patient 1 and from 20/600 to 20/100 in Patient 2. CONCLUSION: HSO can be a useful tool in the treatment of persistent macular hole. OCT images showed that the tamponade was effective in the upright position in the foveal region. OCT allowed determination of the time of tamponade removal according to the anatomical stage of hole closure.

Autologous plasmin for pharmacologic vitreolysis prepared 1 hour before surgery.

PURPOSE: To evaluate the safety and efficacy of intravitreal injection of autologous plasmin enzyme (APE) in inducing a posterior vitreous detachment (PVD). APE was obtained by a modified method 1 hour before surgery. METHODS: APE was obtained by centrifugation of autologous whole blood from the patients 1 hour before surgery and by incubation with streptokinase. APE was injected in the vitreous cavity 20 minutes before surgery. This procedure was applied for 20 patients who underwent vitrectomy for macular pucker, macular hole, and macular edema due to vitreoretinal traction. The status of PVD was graded intraoperatively. The plasmin concentration obtained by this method and the plasminogen titer of the plasma from each patient were compared. Activated partial thromboplastin time was controlled before surgery and 1, 6, 12, and 24 hours after surgery to evaluate alteration of the coagulation due to systemic absorption of the plasmin. RESULTS: Preparation of APE was easy and took on average 45 minutes for all patients. A PVD with an evident Weiss ring was observed during surgery in 17 eyes (85%). The average plasmin activity was 0.26 IU/0.2 mL activated plasma. The partial thromboplastin time did not show any alteration in any of the patients with respect to preoperative values. CONCLUSION: APE obtained by this method can lead to a PVD and facilitate the complete remotion of vitreous cortex. The intravitreal injection does not lead to alteration of systemic blood coagulation.

Modified technique for safer indocyanine-green-assisted peeling of the internal limiting membrane during vitrectomy for macular hole repair.

BACKGROUND: During macular hole surgery, indocyanine green (ICG) has access to the subretinal space and can lead to toxic and phototoxic damage of the retinal pigment epithelium (RPE). To reduce its toxicity and to avoid contact between ICG and the RPE, we have developed a modified technique by using autologous whole blood. METHODS: Thirty-one eyes underwent vitrectomy for idiopathic macular hole repair. Autologous whole blood (0.1 ml) was injected into the buffered saline solution (BSS)-filled vitreous cavity over the posterior pole and aspirated with a flute cannula. A small clot remained covering the macular hole. The internal limiting membrane (ILM) was stained by using 0.05% ICG solution. The ICG was dissolved in 5% glucose to obtain an iso-osmotic solution. This ICG was injected into the BSS-filled vitreous cavity over the posterior pole and removed after 10 s. The ILM was peeled and a long-acting gas tamponade applied. Pre- and postoperative best-corrected visual acuity and optical coherence tomography (OCT) findings are reported. RESULTS: Macular hole closure was achieved in 30 of 31 eyes (97%). The mean preoperative logMAR acuity was 0.99 (range: 0.4 to 2.0). Mean postoperative logMAR acuity was 0.496 (range: 0.0 to 1.0). The average improvement in vision was 0.66 logMAR units (range: 1.5 to 0.0). No postoperative RPE alterations were observed biomicroscopically or on OCT. CONCLUSION: This surgical technique leads to favorable anatomic and functional results. ICG toxicity is reduced by modifying osmolarity, concentration and contact time and by injecting ICG under BSS. Autologous whole blood acts as a mechanical barrier and prevents ICG from entering in the subretinal space.

The combined use of perfluorohexyloctane (F6H8) and silicone oil as an intraocular tamponade in the treatment of severe retinal detachment.

BACKGROUND: The purpose of this study was to investigate the combined use of perfluorohexyloctane (F6H8) and 1,000-centistoke silicone oil as a long-term intraocular tamponade in the treatment of complicated retinal detachment. METHODS: Sixty consecutive eyes affected by complicated retinal detachment with (1) retinal breaks of the lower two quadrants and severe proliferative vitreoretinopathy, (2) inferior giant retinal tear, (3) penetrating trauma or (4) choroidal detachment underwent pars plana vitrectomy using a combined internal tamponade of F6H8 and silicone oil. The double filling (DF) was removed after 40-50 days. The anatomical outcome and the complications due to the DF are reported. RESULTS: Retinal reattachment was achieved in all but one patient. Thirty-eight (63%) eyes needed further surgery with silicone oil tamponade. Silicone oil was successfully removed in 22 eyes. Sixteen (27%) eyes had retained silicone oil at the last follow-up examination. One eye showed persistent retinal detachment despite further surgery. Main complications of the DF were recurrent retinal detachment of the upper retina in six (10%) eyes and membrane formation in 25 (42%) eyes. CONCLUSIONS: A combined internal tamponade of F6H8 and silicone oil may be a useful tool in the treatment of complicated retinal detachment involving the lower quadrants of the retina.

25-gauge, sutureless vitrectomy and standard 20-gauge pars plana vitrectomy in idiopathic epiretinal membrane surgery: a comparative pilot study.

BACKGROUND: The aim of the study was to evaluate the safety and functional outcome of a small incision, sutureless vitrectomy in the treatment of idiopathic epiretinal membranes (ERM) compared with a standard 20-gauge vitrectomy system. METHODS: Forty-six consecutive patients with idiopathic ERM were recruited for this study and prospectively evaluated. In group 1 (n=26) we used a transconjunctival sutureless 25-gauge vitrectomy system (TSV), patients in group 2 (n=20) were operated on using a standard 20-gauge vitrectomy system. The ERM was removed and the internal limiting membrane (ILM) was peeled in all eyes. Surgery-related complications, operating time, intraoperative balanced salt solution (BSS) consumption, postoperative discomfort, postoperative intraocular inflammation, lens opacification, and long-term visual outcome are reported and compared. RESULTS: No surgery-related complications were observed in either group. Operating time was shorter in group 1 compared with group 2 (mean 15.6 and 29.6 min respectively). Intraoperative amount of BSS consumption was less in group 1 (mean 28 ml in group 1 and 42 ml in group 2). Postoperative discomfort and intraocular inflammation were significantly reduced in the 25-gauge group. In the 20-gauge group cataract formation requiring surgery was observed in two eyes. Visual acuity improved significantly in both groups. The 25-gauge group improved on average by more lines of vision and the improvement in vision was more rapid. CONCLUSION: The TSV system is a safe and efficient surgical technique for ERM surgery. Operating time is significantly reduced, minimizing surgery-induced trauma, and reducing postoperative intraocular inflammation and the patients' discomfort. The incidence of cataract formation may be less using TSV. Postoperative recovery is accelerated.

A pilot study on the use of silicone oil-RMN3 as heavier-than-water endotamponade agent.

AIMS: This work was conducted to report an interventional non-comparative pilot study using Oxane HD, a mixture of ultra-purified silicone oil and RMN3, a partially fluorinated olefin, as heavier-than-water internal tamponade. METHODS: Twenty-eight consecutive patients were recruited for this study. Indications included recurrent retinal detachment (RD) with proliferative vitreoretinopathy (PVR) (stage > or =C2) arising from inferior or posterior tears, recurrences after vitreoretinal surgery, penetrating trauma and combined rhegmatogenous and choroidal detachment. The patients underwent a pars plana vitrectomy, membrane peeling, and Oxane HD was used as long-term internal tamponade. RESULTS: Oxane was removed after 88 days (range 45-96 days) and exchanged with BSS in five eyes, long-acting gas in 14 eyes and with silicone oil in nine eyes. Retinal reattachment was achieved in 15 eyes. The overall anatomical success rate obtained using Oxane HD was 53.5%. In 15 patients with previous marked scleral buckling, the success rate was 26%: in nine patients recurrent RD occurred in the inferior sector, in five patients new tears were detected in the lower sectors; membrane formation was observed in 15 eyes. In 13 patients without marked scleral indent, the success rate was 84.6%. There was no evidence of dispersion and excessive inflammation. CONCLUSION: Oxane HD may be a useful tool in complicated RD with large inferior breaks, inferior PVR or combined rhegmatogenous, and choroidal detachment without marked scleral buckling, which put the eye profile out of shape, led to a higher failure rate and reduced the tamponading effectiveness of Oxane HD.

Long-term vitreous replacement with perfluorohexyloctane and silicone oil: preliminary reports of a multicentric study.

AIM: To report on the use of a combined intra-ocular tamponade with silicone oil and perfluorohexyloctane (F(6)H(8)) in the treatment of complex retinal detachment. DESIGN: A prospective consecutive interventional case series from seven study centres. PARTICIPANTS: 69 patients presenting a retinal detachment with proliferative vitreoretinopathy (PVR) and retinal breaks of the inferior two quadrants of the fundus. METHOD: Patients were divided into two groups: (1) 28 eyes which had not been operated on before; (2) 41 eyes affected by recurrent retinal detachment that had had unsuccessful previous surgery with silicone oil or gas tamponade. A pars plana vitrectomy, membrane peeling and -- when necessary -- a retinotomy were performed; the vitreous cavity was filled with two thirds of F(6)H(8) and one third of silicone oil 1,000 mPas (double filling, DF). The endotamponade was removed after 30-45 days (median 38) and replaced by balanced salt solution or silicone oil according to the condition of the retina. RESULTS: Retinal reattachment was achieved in 52 out of 69 cases (75%) 6 months after removal of the DF without any endotamponade. CONCLUSION: The DF with F(6)H(8) and silicone oil allows a good endotamponading to the inferior retina and the posterior pole. The DF appeared to be well tolerated. Further studies are necessary to evaluate whether a DF is advantageous in respect to silicone oil filling alone in case of retinal breaks and PVR of the inferior retina.