Merin Saul, Obolensky Alexey, Farber Marilyn D, Chowers Itay
Department of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
J Ocul Pharmacol Ther. 2008 Feb;24(1):80-6. doi: 10.1089/jop.2007.0022.
The aim of this study was to assess the neuroprotective effect of a topical alpha2-agonist in patients with retinal dystrophies.
This study was a prospective, placebo-controlled, double-masked, randomized clinical trial. A total of 26 patients with retinal dystrophies were included. One (1) randomly selected eye was treated with brimonidine tartrate 0.2% twice-daily, while the fellow eye received artificial tears. Disease progression parameters tested at 6-8-month intervals throughout the study included Goldmann visual fields, contrast sensitivity, color vision, and fullfield electroretinography.
Seventeen (17) of the 26 recruited patients completed the study. Except for 1 patient with an 18-month follow-up, all patients were followed up for 24-36 months (mean, 29). At the conclusion of the study, there were no differences detected in visual acuity, color vision, and contrast sensitivity between the treated and control eyes. There was a trend, however, toward a lesser degree of visual field loss in the brimonidine-treated eyes. There was also a delay in the time required to reach a 25% visual field loss in the treated eyes. These differences were more pronounced in a subgroup of patients diagnosed as retinitis pigmentosa and with visual fields of 5 cm2 or more at baseline.
The findings of this pilot study suggest a trend for slower progression in the eyes of patients with retinal dystrophy when treated with brimonidine, according to one of the parameters that was studied (visual field loss). Further studies that include a larger number of patients and a longer follow-up period are needed to clarify and confirm the potential neuroprotective effect of alpha2-agonists in human retinal dystrophies.
本研究旨在评估局部应用α2激动剂对视网膜营养不良患者的神经保护作用。
本研究为前瞻性、安慰剂对照、双盲、随机临床试验。共纳入26例视网膜营养不良患者。随机选择一只眼每天两次使用0.2%酒石酸溴莫尼定治疗,而对侧眼使用人工泪液。在整个研究过程中,每隔6 - 8个月测试的疾病进展参数包括Goldmann视野、对比敏感度、色觉和全视野视网膜电图。
26例招募患者中有17例完成了研究。除1例随访18个月的患者外,所有患者随访24 - 36个月(平均29个月)。在研究结束时,治疗眼和对照眼在视力、色觉和对比敏感度方面未发现差异。然而,酒石酸溴莫尼定治疗的眼睛有视野损失程度较小的趋势。治疗眼达到25%视野损失所需的时间也有所延迟。这些差异在诊断为视网膜色素变性且基线视野为5平方厘米或更大的患者亚组中更为明显。
根据所研究的参数之一(视野损失),这项初步研究的结果表明,酒石酸溴莫尼定治疗视网膜营养不良患者的眼睛时,有进展较慢的趋势。需要进一步开展包括更多患者和更长随访期的研究,以阐明并确认α2激动剂对人类视网膜营养不良的潜在神经保护作用。