Hertle Richard W, Yang Dongsheng, Adkinson Tonia, Reed Michael
Children's Hospital Medical Center, Akron, Ohio, USA Department of Ophthalmology, SUMMA Medical Center, Akron, OH, USA NEOMED, Rootstown, OH, USA.
Children's Hospital Medical Center, Akron, Ohio, USA NEOMED, Rootstown, OH, USA.
Br J Ophthalmol. 2015 Apr;99(4):471-6. doi: 10.1136/bjophthalmol-2014-305915. Epub 2014 Oct 21.
To test the hypothesis that the topical carbonic anhydrase inhibitor brinzolamide (Azopt) has beneficial effects versus placebo on measures of nystagmus and visual acuity in adult subjects with infantile nystagmus syndrome (INS).
Prospective, cross-over, double masked clinical trial.
Single centre.
Five subjects ≥18 years old with typical INS and best-binocular visual acuity in their primary position null zone ETDRS 55 letters to 85 letters (20/200 to 20/50) and had no previous treatment for nystagmus.
In a randomised order, each subject received one drop of Azopt or placebo in both eyes three times a day separated by a washout period of at least a week followed by Azopt or placebo in both eyes three times a day; thus each subject got the drug and placebo, each acting as his or her own control.
The nystagmus acuity function and INS waveforms obtained from eye movement recordings, binocular optotype visual acuity, using the ETDRS protocol analysed individually and as a group before and after Azopt and placebo.
Versus placebo and baseline measures, topical Azopt significantly improved; INS waveform characteristics in the primary position null zone, group mean values of the nystagmus acuity function across gaze (p<0.01) and group mean ETDRS binocular letter visual acuity (p<0.05). There was a predictable decrease in intraocular pressure (IOP) without any systemic or ocular adverse events.
Although a prospective large-scale clinical trial is needed to prove effectiveness, an eye-drop-based therapy for INS may emerge as a viable addition to optical, surgical, behavioural and systemic drug therapies for INS.
NCT01312402.
检验以下假设：对于患有婴儿型眼球震颤综合征（INS）的成年受试者，局部碳酸酐酶抑制剂布林佐胺（Azopt）与安慰剂相比，在眼球震颤和视力测量方面具有有益效果。
前瞻性、交叉、双盲临床试验。
单中心。
5名年龄≥18岁的典型INS受试者，其双眼在第一眼位无像区的最佳视力为ETDRS视力表55至85个字母（20/200至20/50），且既往未接受过眼球震颤治疗。
按照随机顺序，每位受试者双眼每天滴入一滴Azopt或安慰剂，每日3次，中间间隔至少1周的洗脱期，之后双眼每日3次滴入Azopt或安慰剂；因此，每位受试者均接受了药物和安慰剂治疗，且各自作为自身对照。
通过眼动记录获得眼球震颤视力功能和INS波形，使用ETDRS方案测量双眼视标视力，在使用Azopt和安慰剂前后分别单独及作为一组进行分析。
与安慰剂及基线测量相比，局部使用Azopt可显著改善：第一眼位无像区的INS波形特征、注视时眼球震颤视力功能的组均值（p<0.01）以及ETDRS双眼字母视力的组均值（p<0.05）。眼压出现了预期的降低，且未发生任何全身或眼部不良事件。
尽管需要进行前瞻性大规模临床试验来证实有效性，但基于滴眼液的INS治疗可能会成为INS光学、手术、行为及全身药物治疗之外的一种可行补充方法。
NCT01312402。
