Objective To evaluate whether radiation may offer a practical method of improving surgical success for glaucoma drainage surgery in South Africa. Design Double blind, randomised controlled trial. Setting Three public hospitals in South Africa. Participants 450 black Africans with primary glaucoma. Interventions Trabeculectomy with 1000 cGy radiation or standard trabeculectomy without radiation (placebo). Main outcome measures Primary outcome measure was surgical failure within 12 months (intraocular pressure > 21 mm Hg while receiving no treatment for ocular hypotension). Secondary outcomes were visual acuity, surgical reintervention for cataract, and intraoperative and postoperative complications. Results 320 people were recruited. radiation was given to 164; 20 (6%) were not seen again after surgery. One year after surgery the estimated risk of surgical failure was 30% (95% confidence interval 22% to 38%) in the placebo arm compared with 5% (2% to 10%) in the radiation arm. The radiation group experienced a higher incidence of operable cataract (18 participants) than the placebo group (five participants; P = 0.01). At two years the estimated risks with placebo and radiation were, respectively, 2.8% (0.9% to 8.3%) and 16.7% (10.0% to 27.3%). Conclusion radiation substantially reduced the risk of surgical failure after glaucoma surgery. Some evidence was, however, found of an increased risk for cataract surgery (a known complication of trabeculectomy) in the radiation arm during the two years after surgery. Trial registration ISRCTN62430622.
A multicentre randomized controlled trial was established in Pretoria, Bloemfontein and Edendale in South Africa, and coordinated from London. The purpose of the trial was to determine the efficacy of low-dose beta irradiation of glaucoma. Five communication modalities (telephone, fax, e-mail, videoconferencing and face-to-face meetings) were examined in terms of their benefits in a multicentre trial. The eight stages of the multicentre trial examined were: set-up and training, recruitment, standardization, patient management, data transmission, update and data dissemination, clinical follow-up and monitoring, and publication. On four-point Likert scales for rating the usefulness of the communication modalities at each of the eight stages of the trial (from 0 = not useful to 3 = very useful; maximum score 24) the telephone was given a total score of 10, fax 9, e-mail 13, videoconferencing 15 and face-to-face meetings 9. Telemedicine techniques offer considerable benefits in the coordination of multicentre trials by improving data collection, maintaining the efficacy and monitoring of trials, while potentially offering reduced costs in terms of travel and time. The realtime scrutiny of patient records helps to ensure data uniformity and completeness of data collection. Videoconferencing was most useful when considered as one of several communication tools that can be used to improve the effectiveness of a service or process.
A method of combined cataract extraction and trabeculectomy using phacoemulsification through a modified 5 mm sutureless scleral tunnel incision is described. In eight patients who were followed for a minimum of five months in an initial series, the intraocular pressure (IOP) decreased to less than 19 mm Hg; six achieved this result at six months on no medication. The IOP decreased from a mean of 30.88 mm Hg preoperatively to 13.75 mm Hg at two months and 14.00 mm Hg at six months. The preoperative mean of 3.63 antiglaucoma medications per patient decreased to 0.25 postoperatively. Although all patients had advanced glaucomatous optic neuropathy with a preoperative mean cup/disc ratio of 0.79, visual acuity improved in six patients; four patients had an acuity of 20/40 or better at both one week and two months. Surgically induced astigmatism averaged 0.57 diopter (D) at two months, with a mean astigmatic shift of 0.08 D with the rule at two months and 0.41 D with the rule at three months. No hypotonous or flat anterior chambers were encountered; there were visible blebs in seven patients at six months. The sutureless phacotrabeculectomy preserves all the advantages of small incision phacoemulsification and appears to be a safe and effective combined procedure for IOP control in glaucoma patients with cataracts.
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