Iodine Plaque Brachytherapy a Customized Conservative Approach to the Management of Medium/Large-sized Uveal Melanoma.

BACKGROUND/AIM: The objective of this study was to assess the role of iodine (125I) plaque brachytherapy in the management of uveal melanoma. PATIENTS AND METHODS: This is a retrospective study of 50 patients (median age 67 years; range=33-86 years) with uveal melanoma, treated with 125I plaque brachytherapy at the University Hospital of Pisa. Uveal melanoma was diagnosed with A-scan and B-scan standardized echography, fluorescein angiography, indocyanine green-angiography, optical coherence tomography, and/or magnetic resonance imaging. The primary outcomes assessed were local control, overall survival, disease progression, globe preservation, and metastases. Secondary outcomes were acute and late radiation adverse effects. RESULTS: Inclusion criteria comprised Eastern Cooperative Oncology Group performance status ≤2, life expectancy >6 months, and tumor thickness ≤10 mm and\or diameter ≤20 mm. All the patients were treated with 125I plaque brachytherapy, with a prescription dose of 85 Gy to the tumor apex. The 5-year rate of local control, progression-free survival, metastasis-free survival, enucleation-free survival, and overall survival were 83.0%, 81.4%, 90.3%, 83.1%, and 92.1% respectively. Twenty-four patients (48.0%) had one or more acute and late toxicities. The most common acute adverse events (CTCAE vs. 5.0) grade 1-3 were conjunctivitis and eye pain (6.0%). Regarding late events, radiation retinopathy grade 1-3 occurred in 18.0% of cases, while grade 1-3 vitreous hemorrhage in 2.5%. CONCLUSION: 125I plaque brachytherapy offers an effective and safe approach for selected cases of uveal melanoma, due to the reported satisfactory results in terms of local control, eye conservation and survival.

Photon-based high-dose single-fraction radiosurgery, an effective treatment modality for recurrent uveal melanoma.

Introduction: To evaluate and report the outcome of a patient with locally recurrent uveal melanoma (UM) previously treated with brachytherapy (BT), using a second personalized globe-sparing radiotherapy approach. Material and methods: In June 2020, a 78-year-old man arrived at our institution with diplopia and suspected uveal melanoma. At the ophthalmological evaluation (B-scan and A-scan ultrasonography) a lesion in the right eye at 6-7 hours of about 5 mm thickness, with internal lacunar areas, approximately 7 mm away from the limbus, was observed. The patient underwent ruthenium plaque BT at a total dose of 110 Gy prescribed to the apex of the tumour. At the follow-up, the lesion was under control until September 2021, but it recurred with a satellite exudative detachment in the lower and temporal sectors 7-10 hours. At the B-scan the lesion had a maximum thickness of 4.6 mm. Subsequently, in a multidisciplinary discussion, one single fraction stereotactic radiosurgery was scheduled. The prescribed dose was 27 Gy in the de-novo lesion and 24 Gy in the previously irradiated site. Stereotactic radiosurgery was performed in October 2021. Results: The time interval between the 2 treatments was 15 months. Twenty months after recurrence, local tumour control was observed, and no metastases were detected on follow-up examinations. No severe acute or late toxicity was observed due to the retreatment. Conclusions: Photon stereotactic radiotherapy is a feasible, acceptably tolerated modality, and it represents an eye-preserving treatment also for patients with recurrent UM unfit for BT.

An empirical approach to the definition of the target margins in eye radiosurgery.

INTRODUCTION: A system for stabilizing and monitoring eye movements during LINAC-based photon beam one single fraction stereotactic radiotherapy was developed at our Institution. This study aimed to describe the feasibility and the efficacy of our noninvasive optical localization system that was developed, tested, and applied in 20 patients treated for uveal melanoma. METHODS: Our system consisted of a customized thermoplastic mask to immobilize the head, a gaze fixation LED, and a digital micro-camera. The localization procedure, which required the active collaboration of the patient, served to monitor the eye movements during all phases of the treatment, starting from the planning computed tomography up to the administration of radiotherapy, and allowed the operators to suspend the procedure and to interact with the patient in case of large movements of the pupil. RESULTS: Twenty patients were treated with stereotactic radiosurgery (27 Gy in one fraction) for primary uveal melanoma. All patients showed a good tolerance to the treatment; until now, all patients were in local control during the follow up and one died for distant progression 6 months after radiosurgery. CONCLUSIONS: This study showed that this noninvasive technique, based on eye position control, is appropriate and can contribute to the success of LINAC-based stereotactic radiotherapy. A millimetric safety margin to the clinical target volume was adequate to take account for the organ movement. All patients treated till now showed a good local control; failures in the disease control were due to metastatic spread.

Photon-based High-dose Single-fraction Radiosurgery, an Effective Treatment Modality for Large and Posterior Uveal Melanoma.

BACKGROUND/AIM: Uveal melanoma (UM) is the most common primary intraocular malignant tumor. This malignancy is frequently treated using brachytherapy, stereotactic radiotherapy, or proton therapy. The objective of this study was to assess the role of stereotactic radiosurgery in the treatment of large and posterior UM. PATIENTS AND METHODS: From January 2014 to July 2021, we treated 65 patients (median age=71 years; range=31-89 years) affected by UM. Inclusion criteria were Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2, life expectancy >6 months, tumor thickness >10 mm, diameter >16 mm or posterior UM. The treatment was delivered with a True Beam™ LINAC with arc modulation technique. All patients received 27 Gy in one fraction (biological effective dose ≈100 Gy, assuming an α/ß of 10). RESULTS: The median follow-up was 36 (range=3-90) months. Acute toxicities were reported in 14 patients, whereas late toxicity occurred in 45 (69.2%). Fifteen patients (23.0%) underwent enucleation: eight (12.3%) for failure of local control and seven (10.7%) for late treatment co-morbidities. The 5-year local control, and progression-free, metastasis-free, enucleation-free, and overall survival rates were 80%, 43%, 62%, 65% and 56%, respectively. In multivariate analysis, tumor dimensions significantly influenced survival [larger basal diameter: progression-free [hazard ratio (HR)=2.42] and overall (HR=2.61) survival; greater thickness: overall survival (HR=2.36)]. In multivariate analysis, patients without local control had a higher risk of distant metastasis (HR=3.25). CONCLUSION: Stereotactic radiosurgery offers an effective and safe approach for selected cases of UM due to the satisfactory results in terms of local control, eye conservation and survival.

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.

Suprachoroidal drug infusion for the treatment of severe subfoveal hard exudates.

PURPOSE: To evaluate the safety, feasibility, and preliminary efficacy of suprachoroidal drug delivery with a microcatheter for the treatment of severe subfoveal hard exudates (SHE) in retinal vasculopathies. Definitive treatments for SHE have not yet been identified and prognosis is unfavorable. METHODS: In this prospective, interventional pilot study, six eyes of six patients with central or branch retinal vein occlusion or diffuse diabetic macular edema accompanied by massive refractory SHE underwent a single treatment with bevacizumab and triamcinolone administered to the submacular suprachoroidal space via a microcatheter introduced at the pars plana and advanced posteriorly. The main outcome measures included best-corrected visual acuity, vascular leakage, macular thickness, extent of SHE, and complications. RESULTS: Mean follow-up was 12 months. Three eyes had central retinal vein occlusion, one had branch retinal vein occlusion, and two had chronic diabetic macular edema. Best-corrected visual acuity improved by ≥2 lines in 4 eyes and remained stable in 2 eyes. At 1 month to 2 months postprocedure, SHE was almost completely resolved in all eyes and macular edema was significantly reduced. There were no surgical or postoperative complications. CONCLUSION: Suprachoroidal infusion of drugs can be effective in reabsorbing massive SHE.

Heavy silicone oil (Densiron-68) for the treatment of persistent macular holes: Densiron-68 endotamponade for persistent macular holes.

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.

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.

Modified incision in 25-gauge vitrectomy in the creation of a tunneled airtight sclerotomy: an ultrabiomicroscopic study.

BACKGROUND: The standard straight incision for 25-gauge vitrectomy may not close well at the end of surgery with post-operative hypotony. To overcome incompetent wound closure, oblique insertion of the trocars has been suggested. More recently we have developed an oblique incision. which is parallel to the scleral fibres instead of perpendicular and therefore avoids cutting. The aim of this study was to compare the effectiveness of the different incisions and to investigate their behaviour with the UBM. METHODS: 45 patients affected by macular holes were operated; in 15 eyes using oblique-parallel insertion (OPAI), in 15 oblique-perpendicular (OPEI) and in 15 straight incision (SI). Patients underwent UBM examinations 1 day, 1 week, 1 month p.o. RESULTS: OPAI was airtight after the removal of 25 g cannulas. UBM examination 1 day post-operatively (p.o) showed the 45 sclerotomies were well healed with perfect apposition of the internal wound lips. 39 sclerotomies were undetectable, 6 slightly evident. With OPEI the incisions were airtight at the end of surgery. At the 1 day p.o. UBM examination the 45 sclerotomies were well-healed but a minimal gape was clearly visible in all of them, 3 eyes showed peripheral cilio-choroidal (CCD) detachment, which was resolved after 7 days although the gape was still evident. At 1 month p.o. examination the gape was not detectable in 20 sites, evident in 25. With SI at the end of the surgery conjunctival bleb formation was detected in 10 cases, air-gas refilling was performed in 7 eyes and 3 sclerotomies were sutured. At 1 day p.o. hypotony was recorded in 5 patients, recovering at the 7 day follow-up. At the 1 day p.o. UBM examination showed a significant gape in all sites, weak vitreous entrapment was shown in 36, subconjunctival fluid in 4, CCD in 7. At the 7 day UBM the CCD had disappeared in 4 and was reduced in 3. At the 1 month p.o. the sclerotomy defect was still detectable but other complications were no longer evident. CONCLUSIONS: OPAI achieved the quickest and most complete sealing since the 1st day p.o without complications, therefore it could be safer when performing 25-g vitrectomy with extensive manipulation.

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.

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.

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.