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242 IVANDIC AND IVANDIC Diagram showing how low-level laser therapy was given. For the right eye the laser beam was placed at a dis- tance of 1 cm and pointed towards the macular area. Patients and Methods Study design This study of a case series was conducted in accordance with the Helsinki declaration. Informed consent was ob- tained from all patients before entry into the study. Data were collected at a single non-institutional center in Ger- many during a 7-year period and were evaluated retrospec- tively . Patients Patients with AMD of all stages (dry to wet exudative forms with or without cataracts) were included if their vi- sual acuity was 20/20. Patients were excluded if they had concomitant diseases that would impair vision except for new cataracts, or if they had received any prior treatment that could have affected vision; patients with visual acuity 20/20 were also excluded. Laser For LLLT, a semiconductor laser diode with continuous emission at 780 nm (7.5 mW, 292 Hz) fitted with collimating optics (spot diameter 3 mm) in a handheld casing was used. The laser diode was driven by an apparatus that al- lowed low-frequency switching of the laser beam and pro- vided automatic power control (Bimed, Munich, Germany). In an initial experiment, the extinction of laser light ( 780 nm) was examined in a freshly enucleated pig eye (22 24 mm) to determine the lowest penetrating laser power re- quired for the laser energy to reach the RPE and retina. Power output was measured using a LC-U-2E power meter (Laser Components GmbH, Olching, Germany). Treatment As illustrated in Fig. 1, laser radiation was applied transconjunctivally to the macula for 40 sec (0.3 J/cm2). Dur- ing LLLT the eye was in adduction; if necessary, the lids were fixed manually. Four treatments were administered (two treatments per week) resulting in a total dose of 1.2 J/cm2. Ten patients with AMD (n 20 eyes) were randomly selected to receive mock treatment (control group); the laser beam was directed above the nose without contacting the eye. An audible signal heard every 10 sec was interpreted by the patients as treatment. During the treatment period, no other therapy was applied. Measurements Eyes were examined before inclusion, prior to each treat- ment session, and at the end of the study. Visual acuity was assessed by projection of American Optical optotypes (Snellen) at a distance of 20 feet after optimal correction of refraction with blinding. In order to avoid patient memo- rization of the letters, only unknown optotypes were pre- sented each time. Color vision was examined by use of a de- saturated color test (Farnsworth D-15 series). The Amsler test was used to screen central scotomas. To assess treatment safety, the investigator examined the patients’ eyes before and after each treatment session and asked patients about their general well-being by asking non- leading questions. Data analysis Data on visual acuity were analyzed by calculating the changes in visual acuity (end of study versus baseline); data were transformed logarithmically to allow presentation of results as logarithmic minimal angle resolution (log MAR). For statistical analysis, a t-test for paired observations was used. FIG. 1. TABLE 1. EXTINCTION OF LASER LIGHT ( 780 NM) THROUGH THE OCULAR LA YERS IN PIG’S EYE Input laser power, I0 (mW) 10.5 Output laser Tissue(s) power, I (mW) Cornea 10.5 Lens 11.0 Sclera 4.2 Choroidea 2.9 RPE 1.5 Retina 8.8 Conjunctiva-sclera- 0.2 Extinction (E log I0/I) 0 0.20 0.397 0.558 0.845 0.076 1.720 choroidea-RPE-retina RPE, retinal pigmented epithelium.PDF Image | Low-Level Laser Therapy Improves Vision in Macular Degeneration
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