A prospective randomised study on low-dose transpupillary thermotherapy versus photodynamic therapy for neovascular age-related macular degeneration.

AIM: To compare the efficacy of low-dose transpupillary thermotherapy (TTT) and verteporfin photodynamic therapy (PDT) in patients with occult neovascular age-related macular degeneration (AMD). METHODS: Patients were randomised to receive either low-dose TTT (136 mW/mm) (and sham PDT) (n = 52) or PDT (and sham TTT) (n = 46) with retreatment if leakage was documented by fluorescein angiography. At baseline and at every follow-up, best corrected visual acuity (BCVA) was measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, lesion size on fluorescein angiography and foveal thickness with optical coherence tomography. The primary outcome measure was the proportion of patients who lost <15 letters at 12 months' follow-up. Secondary outcome measures included the proportion of patients who gained >/=0 letters, the change in mean lesion size and the change in foveal thickness at 12 months' follow-up. RESULTS: The percent of patients losing fewer than 15 letters at 12 months was 75.0% in the TTT group and 73.9% in the PDT group (p>0.05). The percent of patients with preserved or improved BCVA was 36.5% in the TTT group versus 23.9% in the PDT group (p>0.05). The mean decrease in foveal thickness was 15% for TTT and 24% (p>0.05) for PDT-treated patients, and the mean increase in total lesion area was -0.7% and -1.1% (p>0.05), respectively. CONCLUSION: In this prospective, randomised trial low-dose TTT and PDT appeared to be equally efficient at stabilising visual acuity in patients with occult neovascular AMD. Low-dose TTT may be considered as an alternative to PDT in this set of patients and also as an adjuvant to pharmacotherapy.

The EORTC ophthalmic oncology quality of life questionnaire module (EORTC QLQ-OPT30). Development and pre-testing (Phase I-III).

AIMS: The research objective was to develop a questionnaire module to be used, in addition to the European Organisation into Research and Treatment of Cancer (EORTC) QLQ-C30, for measurement of quality of life (QL) among patients with uveal melanoma treated with methods such as transpupillary thermotherapy, plaque radiotherapy, proton beam radiotherapy, local resection, and enucleation. The present paper describes the development through Phases I-III. METHODS: Relevant QL issues were generated from literature search and from interviews with ophthalmologists, nurses, and patients with uveal melanoma representing three major treatment options: enucleation, plaque brachytherapy, and proton beam therapy. RESULTS: The provisional module was pretested in 61 patients from Finland, Sweden, and UK. The EORTC QLQ-OPT30 module consists of 26 items for all patients, and four additional items for patients receiving treatments other than enucleation. It measures ocular irritation, vision impairment, headache, worry about recurrent disease, problems with driving, problems with appearance functional problems due to vision impairment, and problems reading. CONCLUSIONS: Several treatment modalities are available for uveal melanoma. There is limited knowledge of the impact of these treatments on QL in the long and short term. We hope that the OPT30 module together with the EORTC QLQ-C30 core questionnaire can be a useful tool in research.

Transpupillary thermotherapy as an adjunct to ruthenium plaque radiotherapy for choroidal melanoma.

PURPOSE: To review the Swedish experience using transpupillary thermotherapy (TTT) as an adjunct to ruthenium plaque radiotherapy for choroidal melanoma. METHODS: A retrospective chart review of 27 patients receiving TTT for juxtapapillary or juxtafoveal growth present at the time of diagnosis, or recurrent growth at the tumour margin, or significant exudation following ruthenium brachytherapy for choroidal melanoma. RESULTS: Follow-up ranged from 6 to 29 months (median=20 months). Tumour growth regressed completely (n=8), regressed partially (n=11), remain unchanged (n=6) or progressed (n=2). Complications included focal lens opacity with or without associated posterior synechiae (n=3), retinal haemorrhage (n=2) and retinal vein occlusion (n=1). Seventeen patients (63%) maintained or improved visual acuity and 2 eyes were enucleated following combined treatment. CONCLUSION: Many of the treated eyes would have been enucleated in the past, suggesting that TTT used in combination with ruthenium brachytherapy improves the short term globe salvage rate. Ocular side effects do occur but are usually not significant.

Transpupillary thermotherapy of occult CNV with no or minimally classic CNV in age-related macular degeneration.

Transpupillary thermotherapy (TTT) has been suggested as a putative treatment for choroidal neovascularization (CNV) in age-related macular degeneration (AMD). This prospective study comprised 66 consecutive patients referred for exudative AMD with predominantly occult subfoveal CNV. Based on fluorescein angiography, there were 38 cases with occult CNV only, and 28 eyes with minimally classic CNV as well. Visual acuity was determined using the logarithmic ETDRS chart. For TTT a diode laser (810nm) with a power of 800 mW or 500-600 mW for a 3.0 mm spot was used (duration 60 sec.). Follow-up included clinical examination with biomicroscopy and fluorescein angiography at 2-3 months and 6 months in all cases. In the entire case material (n = 66), the mean visual acuity was preoperatively 20/125 (47.4 letters) and postoperatively 20/160 (41.8 letters) yielding a decay of 5.6 letters ("one line"). Visual acuity improved in 8 cases (12.1%), deteriorated in 17 (25.8%), and remained stable in 74.2%. In purely occult CNV visual acuity remained stable in 81.6% as compared to 64.3% in occult & minimally classic CNV; the former subgroup lost on the average 3.6 letters, the latter 8.3 letters (close to "two lines") over 6 months. The proportion of eyes losing at least 15 letters was 13.2% in purely occult CNV versus 35.7% in the occult & minimally classic subgroup. In 39 of 66 cases (59.1%) fluorescein leakage regressed to staining only concomitant with absorption of subretinal fluid. Complications associated with deterioration of visual acuity (17 cases) included postoperative hemorrhage, increase of exudation on angiography, and progressive fibrosis. The results indicate that TTT stabilizes visual acuity concomitant with regression of exudation and resorption of subretinal fluid in the majority of cases with predominantly occult CNV Cases with occult CNV only seem to do better than those with minimally classic CNV as well. The safety and complication rate appear to be acceptable. A randomized controlled trial is in progress.

Improvement of the recurrence-free interval using biological adjuvant therapy in uveal melanoma.

This study was an attempt to compensate for an alleged aetiological deficiency in melanoma by the prophylactic oral administration of the essential biological components missing. Nine random patients suffering from high-risk uveal melanoma (T3) were, in this preliminary study, treated secondarily with biological dietary adjuvants after primary standard therapy, enucleation or brachytherapy. Secondary treatment consisted of certain natural amino-acids, trace-element salts, folic acid and a diet containing neurogenic lipid components. It entailed no side-effects, no toxicity and was inexpensive. None of these nine patients has suffered recurrent disease. The mean follow-up time was over 80 months (median 69, range 58-140 months). Local tumour control was 100%. This clinical result is significantly better (p = 0.018) as compared to similar T3 uveal melanoma patients in standard care who did not receive adjuvant dietary remedies after primary treatment. The control patients consisted of similar adjusted T3 cases selected from the Swedish official registries, and T2 patients from Germany. Based on the previous positive clinical results obtained with cutaneous malignant melanoma in bioimmunotherapy this additional positive result supports the notion that biological components administered orally may compensate for the etiological deficiency leading to malignant melanoma.