From the Department of Clinical Sciences, Ophthalmology, Lund University (A.H., D.P., B.B.); Department of Ophthalmology, Skåne University Hospital (A.H., D.P.), Malmö, Sweden..
From the Department of Clinical Sciences, Ophthalmology, Lund University (A.H., D.P., B.B.); Department of Ophthalmology, Skåne University Hospital (A.H., D.P.), Malmö, Sweden.
Am J Ophthalmol. 2023 Aug;252:286-294. doi: 10.1016/j.ajo.2023.04.010. Epub 2023 May 2.
To compare long-term visual outcomes in the 2 arms of the Early Manifest Glaucoma Trial (EMGT) and determine if delayed treatment was associated with a penalty in terms of visual function.
Long-term follow-up of a prospective, randomized controlled clinical trial.
EMGT was carried out at 2 centers in Sweden; 255 subjects with newly detected, untreated glaucoma were randomized to immediate treatment with topical betaxolol and argon laser trabeculoplasty or to no initial treatment as long as no progression was detected. Subjects were followed prospectively with standard automated perimetry, visual acuity measurements, and tonometry for up to 21 years. Outcomes included vision impairment (VI), the perimetric mean deviation (MD) index and rate of progression, and visual acuity.
At study end, percentages of eyes with VI or blindness were slightly higher in the treated group than in the untreated control group, 12.1% vs 11.0%, and 9.4.% vs 6.1% respectively, as were subjects with VI in at least one eye, 19.5% vs 18.7%. The differences were not statistically significant, nor were cumulative incidences of VI in at least one eye. The control group had more field loss than the treatment group, with median MD in the worse eye of -14.73 dB vs -12.85 dB, and rate of progression of -0.74 vs -0.60 dB/y, which was not statistically significant. Differences in visual acuity were minimal.
Delaying treatment did not result in serious penalties. VI occurred at similar proportions in both treatment arms with a slight preponderance in the treatment group, whereas visual field damage was slightly higher in the control group.
比较早期显性青光眼试验(EMGT)两个治疗组的长期视力结果,并确定延迟治疗是否会对视力功能产生不利影响。
前瞻性、随机对照临床试验的长期随访。
EMGT 在瑞典的两个中心进行;255 例新诊断、未经治疗的青光眼患者被随机分为立即接受局部贝他洛尔和氩激光小梁成形术治疗组或不进行初始治疗组,只要没有发现进展。对患者进行前瞻性标准自动视野计、视力测量和眼压检查,随访时间长达 21 年。结果包括视力障碍(VI)、视野平均偏差(MD)指数和进展率以及视力。
研究结束时,治疗组的视力障碍或失明眼比例略高于未治疗对照组,分别为 12.1%和 11.0%,至少一眼视力障碍的患者比例分别为 19.5%和 18.7%。差异无统计学意义,至少一眼视力障碍的累积发生率也无差异。对照组的视野丧失比治疗组多,最差眼的中位 MD 为-14.73dB 与-12.85dB,进展率为-0.74dB/y 与-0.60dB/y,差异无统计学意义。视力差异极小。
延迟治疗并未导致严重后果。两组治疗组的 VI 发生率相似,但治疗组略占优势,而对照组的视野损害略高。