Efficacy and safety of ketotifen fumarate 0.025% in the conjunctival antigen challenge model of ocular allergic conjunctivitis

PURPOSE: To determine the duration of action of ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model. DESIGN: Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study. METHODS: Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups. RESULTS: For both studies, ocular itching and vascular injection were significantly reduced (P <.003) at all time points after instillation of ketotifen, with a maximum reduction at 7 minutes postchallenge. In study 2, chemosis, tearing, and lid swelling were also assessed and were significantly reduced (P <.008) after instillation of ketotifen. CONCLUSIONS: Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.     

Short-term ocular tolerability of dorzolamide 2% and brinzolamide 1% vs placebo in primary open-angle glaucoma and ocular hypertension subjects

PURPOSE: To compare ocular tolerability of dorzolamide 2%, brinzolamide 1%, and placebo given three times daily. METHODS: A prospective, double-masked, three-centre, crossover comparison in which 25 ocular hypertensive or primary-open angle glaucoma subjects were randomized to receive dorzolamide, brinzolamide, or placebo three times daily for 3 days. Intraocular pressure, visual acuity, a visual analogue scale, and ocular and systemic symptom queries were completed at the end of each period. RESULTS: After chronic dosing, there was a significant difference in ocular pain on the visual analogue scale among the groups at the 10-s postinstillation time point with dorzolamide having the highest level (22.5+/-28.9) compared to brinzolamide (5.0+/-8.7) or placebo (3.2+/-10.4) (P=0.0006). No differences between groups were observed preinstillation nor following dosing at 3 or 10-min postinstillation. On the initial instillation, the 10-s postinstillation pain was rated as 43.3+/-77.1, which was significantly higher than after chronic dosing (P=0.017). On the ocular symptom query, dorzolamide had the highest incidence of burning/stinging and redness compared to the other groups, but was generally characterized as mild. There were no significant differences in the visual acuity at any time point. CONCLUSIONS: This study suggests that subjects treated with dorzolamide suffer more ocular pain upon instillation compared to brinzolamide or placebo. However, pain symptoms are fewer following chronic dosing and are generally characterized as mild.     

表面麻醉下白内障超声乳化手术对正常眼表的影响

目的:探讨表面麻醉下白内障超声乳化摘除术对正常眼表的影响。方法:对34例(40眼)行白内障超声乳化摘除合并人工晶状体植入术的患者,观察术前、术后3,10d;1,3mo的干眼症状(干涩感、异物感、烧灼感),泪膜破裂时间(BUT)、基础泪液分泌试验(Schinner′I试验)、角膜荧光素染色,并对数据进行统计学分析。结果:白内障超声乳化术后10d内患者有明显的干眼症状,术后3d和10d荧光素试验较术前明显增多;而且泪液分泌量术后10d较术前明显减少(P<0.05);术后1～3mo接近术前水平(P>0.05)。术后3,10dBUT均较术前明显缩短(P<0.05);1～3mo后接近术前水平(P>0.05)。结论:表面麻醉下超声乳化白内障摘除术对眼表具有一定程度的影响,发生机制可能与多种因素有关,临床应积极采取预防、治疗措施。     

The effects of 0.025% hyoscine hydrobromide eyedrops on visual function in man

Instillation of three drops of 0.025% hyoscine hydrobromide into one eye at 5 min intervals caused a mydriasis and cycloplegia of rapid onset and of 4-6 days' duration; this was similar to the previously reported actions of concentrations of up to 0.5%. After refraction for the working distance of the experiments, contrast sensitivity to stationary oscilloscope-generated grating patterns of 10 and 20 c/deg was unaffected despite the mydriasis. Also, contrast sensitivity to laser interference fringes of 10 and 20 c/deg observed in the Maxwellian view, in which the effects of the ocular media are bypassed, was unaffected. Contrast sensitivity to a 3 c/deg phase-reversed grating pattern was, however, transiently reduced by 40% after hyoscine. A second series of experiments showed a deleterious effect of hyoscine on contrast sensitivity to both stationary and phase-reversed grating patterns of 2, 3 and 5 c/deg while contrast sensitivity at 10 c/deg was not consistently affected. These results were explained by a direct deleterious action of hyoscine at the level of the retina, specific to channels that detect low spatial frequencies.     

Effect of topical 0.1% indomethacin solution versus 0.1% fluorometholon acetate on ocular surface and pain control following laser subepithelial keratomileusis (LASEK)

PURPOSE: To compare the effect of topical 0.1% indomethacin solution versus 0.1% fluorometholon acetate in the early postoperative period after LASEK treatment. METHODS: One hundred thirty-five patients undergoing LASEK, having been randomized in a double-masked manner into 2 groups (1 receiving indomethacin and 1 fluorometholon), were evaluated 2-4 days before and 4 days after treatment. We examined corneal fluorescein staining and corneal esthesiometry; the level of pain experienced was reported by the patient on a visual pain scale. In addition, haze was evaluated at 14 +/- 1 weeks after surgery. RESULTS: The pain level and corneal fluorescein staining were significantly less in the indomethacin group. Corneal esthesiometry was reduced to the same extent in the 2 groups. There were no statistically significant differences in haze presentation between the 2 groups. CONCLUSION: Our study highlights the efficacy of indomethacin solution compared with fluorometholon as a pain reducer after LASEK treatment and suggests that indomethacin is associated with a faster epithelial healing process.     

小梁切除术前应用玻璃酸钠滴眼液对术后眼表恢复的促进作用

目的评价3 g·L^-1玻璃酸钠滴眼液术前干预对小梁切除术后眼表恢复的促进作用。方法前瞻性病例对照研究。选取2017年1月至2018年3月于我院住院拟行小梁切除术治疗的原发性慢性闭角型青光眼和原发性开角型青光眼患者52例63眼,随机分为干预组和对照组。干预组从术前1周开始给予3 g·L^-1玻璃酸钠滴眼液,对照组从术后1 d开始给予3 g·L^-1玻璃酸钠滴眼液,均于术后1个月停药。术前两组患者基本情况匹配,比较两组术后1周、1个月和3个月眼表疾病指数(ocular surface disease index,OSDI)、角膜荧光染色评分、泪膜破裂时间(tear break-up time,BUT)和泪液分泌试验结果。结果两组患者术前均有不同程度干眼症状和体征。术后1周两组患者干眼症状均较术前加重,且以对照组症状加重更为显著,表现为OSDI评分和角膜荧光染色评分均较术前增加,BUT较术前缩短(均为P<0.05);术后1个月干预组OSDI评分、角膜荧光染色评分和BUT分别为(14.43±5.33)分、(0.71±0.56)...     

Effect of gefarnate on the ocular surface in squirrel monkeys

PURPOSE: To investigate the ability of gefarnate (geranyl farnesylacetate) to stimulate goblet cell function in the primate eye after a mild alkali injury of the tarsal conjunctiva. METHODS: A bilateral injury was created on the conjunctival surface of the lower eye lid of squirrel monkeys by means of a 30-second application of a 4-mm diameter piece of filter paper wetted with 0.5% NaOH. Gefarnate drops (1%) were administered to one eye of each monkey and vehicle alone in the contralateral eye six times a day, 5 days a week for 4 weeks. Slit-lamp biomicroscopy, impression cytology staining of the ocular surface, fluorescein and rose bengal staining, and Western blot for mucin were performed before injury and weekly thereafter. Light microscopy was used to evaluate the lower conjunctiva. RESULTS: Topical application of gefarnate was not associated with any adverse ocular surface effects. Goblet cell repopulation after injury was significantly greater in the gefarnate-treated eyes compared with the vehicle-treated eyes. In the gefarnate-treated eyes, tear mucin content was significantly greater at 1 week after injury. Fluorescein staining was significantly reduced at 3 weeks after injury, and rose bengal staining was significantly reduced in the area of the wound at 2 weeks in the gefarnate-treated eyes compared with the vehicle-treated eyes; at other times, conjunctival staining in the two groups of eyes was not significantly different. CONCLUSIONS: Gefarnate promotes goblet cell repopulation and increases mucin production after a conjunctival injury. No adverse affects of the treatment were found. Thus, this agent may be useful in conditions that diminish goblet cell function.     

眼表的微生物学

从正常眼表分离的菌丛多为细菌,很少能分离到真菌、病毒和原生动物.从结膜最常分离的细菌包括少量的凝固酶阴性葡萄球菌和类白喉菌属.配戴接触镜个体、HIV阳性个体和免疫缺陷患者的菌丛与正常人相似.慢性眼病患者常携带有更多致病性细菌.几乎所有个体（包括正常个体和患病个体）的正常菌丛都来自于身体其他部位的扩散.     

Focusing on the rational application of 0.1% CsA cationic emulsion in ocular surface inflammatory disorder

Ocular surface inflammatory disorder (OSID) is a chronic ocular disease caused by systemic disorders or involving the local immune system.OSID induces persistent inflammatory reaction in the ocular adnexal connective tissues which in turn give rise to tear hypertonicity and ocular surface epithelial damage, leading to dry eye formation or progression.Common immune-related ocular surface diseases include vernal keratoconjunctivitis, Sjögren syndrome, graft versus host disease, dry eye and immune-related corneal disease, all of which can significantly impact the visual function and quality of life of patients.Current treatments including the use of artificial tears and glucocorticoid eye drops are not always effective and have the risk of adverse events.Cyclosporine A (CsA) is a commonly utilized immunosuppressant that has a strong immunomodulatory effect, but its clinical application is somewhat limited due to the low permeability of its current ophthalmic dosage form.The development of CsA ophthalmic agents has changed the treatment strategy for OSID.The development of 0.1% CsA cationic emulsion has significantly improved the efficacy and safety of topical CsA treatment, which is worth the attention.In order to rationally apply 0.1% CsA cationic emulsion to OSID, ophthalmologists should fully understand the immune-related pathogenesis of each OSID and comprehend the curative effect, indication, application methods and adverse events of topical CsA treatment. © 2023 Henan Institute of Ophthalmology. All rights reserved.     

Effect of latanoprost 0.005% and brimonidine tartrate 0.2% on pulsatile ocular blood flow in normal tension glaucoma

AIM: To determine the effect of brimonidine tartrate 0.2% and latanoprost 0.005% on pulsatile ocular blood flow (POBF) in patients with normal tension glaucoma (NTG). METHOD: NTG patients with progressive optic neuropathy, new disc haemorrhage, or field defects that threatened fixation were enrolled into a randomised, investigator masked, crossover study. Group I patients received 4 weeks each of latanoprost, lubricant, and brimonidine, while group II patients received 4 weeks each of brimonidine, lubricant, and latanoprost. Diurnal POBF was measured at baseline and after each 4 week treatment. RESULTS: 25 patients completed the study and had reliable POBF measurement at each visit. There was no significant diurnal change in baseline POBF (p = 0.768). Latanoprost increased POBF by 213 (SD 257) micro l/min (22.8%, p <0.001) while brimonidine increased it by 97 (183) micro l/min (10.4%, p = 0.014). POBF increased at 8 am (p = 0.004), 12 noon (p = 0.002), and 4 pm (p <0.001) with latanoprost, while it increased only at 8 am (p = 0.016) with brimonidine. After adjusting for the factor of IOP, neither latanoprost nor brimonidine increased POBF significantly. CONCLUSIONS: Latanoprost increases the mean POBF that is related to its IOP lowering effect. The increase in POBF noted after brimonidine is within the range of long term variation and may not be attributable to the drug effect.     

Brimonidine 0.2% vs unoprostone 0.15% both added to timolol maleate 0.5% given twice daily to patients with primary open-angle glaucoma or ocular hypertension

PURPOSE: To compare the efficacy and safety of brimonidine 0.2% vs unoprostone 0.15%, both added to timolol maleate 0.5% each given twice daily. METHODS: In this prospective, multi-centred, double-masked, crossover comparison, patients were randomized to one treatment group for a 6-week treatment period, and then crossed over to the opposite treatment. Measurements were performed at 0800, 1000, 1600, 1800, and 2000 h at baseline and at the end of each treatment period. RESULTS: In all, 33 patients entered this trial and 29 completed. The baseline trough intraocular pressure (IOP) was 23.3+/-2.4 and the diurnal curve IOP was 22.0+/-1.3 mmHg. For the brimonidine and timolol maleate treatment group, the trough IOP was 21.6+/-3.3 and the diurnal curve IOP was 19.8+/-2.1 mmHg, while the timolol and unoprostone treatment showed a trough IOP of 20.9+/-3.8 and a diurnal curve IOP of 19.3+/-2.4 mmHg. There was no significant difference between treatment groups at any time point for the diurnal curve, or in the reduction from baseline (P>0.05). Both treatments failed to statistically reduce the IOP from baseline at 1800 h. There was no difference between treatment groups regarding ocular and systemic unsolicited adverse events, but patients admitted to more dryness (P=0.02) and burning upon instillation (P<0.0001) with unoprostone by survey. CONCLUSION: Brimonidine 0.2% or unoprostone 0.15% added to timolol maleate 0.5% provide similar efficacy and safety throughout the daytime diurnal curve.     

Timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily to patients with primary open-angle glaucoma or ocular hypertension

OBJECTIVE: To compare the efficacy and safety of timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily. DESIGN: Prospective multicenter, randomized, double-masked, crossover comparison study. METHODS: Primary open-angle glaucoma or ocular hypertension patients were randomly assigned to one of the treatment groups for a 6-week treatment period and then crossed over to the opposite treatment. Diurnal curve testing was performed at 8:00 AM, 10:00 AM, 4:00 PM, 6:00 PM, and 8:00 PM at baseline and the end of each treatment period. The run-in medicine was timolol twice daily for 28 days. RESULTS: Thirty-two patients completed this trial. The baseline trough pressure was 24.3 +/- 3.0 mm Hg, and the diurnal curve was 23.4 +/- 3.2 mm Hg. For the fixed combination the treatment trough pressure was 20.8 +/- 4.1 mm Hg and the diurnal curve was 19.6 +/- 3.6 mm Hg, whereas timolol and unoprostone concomitant therapy showed a treatment trough pressure of 20.1 +/- 4.5 mm Hg and a diurnal pressure of 19.8 +/- 4.1 mm Hg. There was no significant difference between treatment groups at any time point, for the diurnal curve, or in the extended reduction from baseline. There was no difference between treatment groups regarding ocular and systemic unsolicited or solicited adverse events. Burning, stinging, and conjunctival hyperemia were the adverse events most noted. There were no serious adverse events during this trial. CONCLUSIONS: This study suggests that both timolol/dorzolamide 2% fixed combination and concomitant timolol maleate 0.5% and unoprostone 0.15% therapy provide similar efficacy and safety throughout the daytime diurnal curve.     

Effects of a 0.9% sodium chloride ophthalmic solution on the ocular surface of symptomatic contact lens wearers

BACKGROUND: Ocular surface-related discomfort is the main reason for stopping contact lens wear. We carried out a study to evaluate the efficacy of preservative-free artificial tears containing 0.9% sodium chloride on ocular surface signs and symptoms in contact lens wearers experiencing discomfort and its possible influence on the duration of contact lens wear. METHODS: We studied 49 contact lens wearers experiencing discomfort who had normal results of slit-lamp biomicroscopy, a fluorescein tear film break-up time (BUT) of 10 seconds or more, and wetting greater than 5 mm in 5 minutes on the Schirmer 1 test with and without anesthesia. Twenty-nine subjects (16 men and 13 women with a mean age of 32.5 years [standard deviation (SD) 8.7 years]) received one instillation of the 0.9% sodium chloride solution four times daily in the lower conjunctival fornix for 21 days. Twenty subjects (12 men and 8 women with a mean age of 35.1 [SD 6.2] years) received no drops and served as a control group. The overall comfort and duration of contact lens wear, results of tear film analysis and adverse events were recorded on days 7 and 21. Patients rated their symptoms (while not receiving any medications or hydrating solutions) on a 100-mm visual analogue scale with "Excellent (lenses not felt)" at the left and "Very uncomfortable (lenses cause irritation or discomfort)" at the right. Measurement of corrected visual acuity, slit-lamp examination, determination of the tear film BUT, the Schirmer 1 test with and without anesthesia, and assessment of the colour and surface of the lens were performed at baseline and at day 21. We analysed the data for the more uncomfortable eye or, if the eyes were equally uncomfortable, the right eye. RESULTS: Significant lessening of ocular discomfort was observed in the treatment group during the study: the mean rating on the visual analogue scale at baseline was 60.2 mm (SD 12.7 mm), compared with 35.8 mm (SD 18.0 mm) at day 21 (p < 0.001, Student's t test). The duration of contact lens wear was significantly longer at day 21 than at baseline (7.0 [SD 2.6] hours vs. 6.4 [SD 2.6] hours, p < 0.05, Student's t test), and the proportion of subjects with conjunctival hyperemia was significantly lower at day 21 (48.3% vs. 82.8%, p < 0.05, chi2 test). No statistically significant changes were observed in tear film BUT, results of the Schirmer 1 test, corneal punctate staining by fluorescein or results of tear film analysis. The treatment was well tolerated by all patients. No significant differences in any of the variables studied were observed in the control group. INTERPRETATION: Treatment with a preservative-free 0.9% sodium chloride ophthalmic solution reduced ocular surface discomfort and extended the duration of contact lens wear without interfering with the tear film or contact lens materials. Long-term studies are needed to confirm the role of this solution in reducing discomfort experienced by contact lens wearers.     

翼状胬肉切除术后应用角膜绷带镜对眼表修复的影响

目的：观察翼状胬肉切除联合角膜缘干细胞移植术后应用角膜绷带镜对眼表修复的影响。

方法：选取2016-01/2018-01在我院眼科就诊的单眼初发翼状胬肉患者52例,行翼状胬肉切除联合角膜缘干细胞移植术加戴绷带镜者26例为试验组,术后不加戴绷带镜者26例为对照组,分别于手术前后观察两组患者眼表疾病指数(OSDI)问卷评分、泪膜破裂时间(BUT)、角膜荧光素染色(CFS)评分。

结果：与对照组相比,术后2wk,1mo试验组患者BUT延长,OSDI、CFS分值降低(均P<0.05)。与术前相比,术后2wk两组患者BUT均缩短,OSDI、CFS分值均增高(P<0.05); 术后1mo试验组患者BUT、OSDI和CFS分值与术前均无差异(P>0.05),而对照组患者BUT较术前仍缩短,OSDI、CFS分值仍增高(均P<0.05)。

结论：翼状胬肉切除联合自体角膜缘干细胞移植后加戴角膜绷带镜在术后早期是一种促进角膜愈合、提高泪膜稳定性、减少术后不适的安全方法,利于眼表修复,具有一定的临床应用价值。     

超声乳化白内障摘除联合小梁切除术对眼表的影响

目的：采用Keratograph 5M眼表综合分析仪比较小梁切除术和超声乳化白内障摘除联合小梁切除术对眼表的影响。

方法：纳入原发性闭角型青光眼合并白内障患者62例62眼,按手术方式分为两组：小梁切除术组32例32眼,超声乳化白内障摘除联合小梁切除术组(青白联合手术组)30例30眼。运用Keratograph 5M评估术前,术后3d,1、 3mo的非侵入性首次泪膜破裂时间(NifBUT)、非侵入性平均泪膜破裂时间(NiaBUT)、泪河高度(TMH)和角膜荧光素染色评分(CFS)。

结果：术前两组患者眼表参数比较差异均无统计学意义(P>0.05)。术后3d青白联合手术组的NiaBUT、NifBUT、CFS、TMH最差,分别为10.13±1.48、12.59±1.96s、0.80±0.22分与0.31±0.02mm,变化幅度明显高于小梁切除组(均 P<0.05),术后1mo两组的各项指标均有所恢复,但直到术后3mo仍未完全恢复到术前水平。

结论：眼表综合分析仪可以客观、精确地用于评估抗青光眼手术后泪膜功能的变化。在术后3mo短期内超声乳化白内障摘除联合小梁切除术比单纯小梁切除术对眼表的影响更为严重,提示在此期间应加强对眼表的护理。     

微切口超声乳化术对糖尿病合并白内障患者眼表的影响

目的：探讨白内障超声乳化手术中2.2及3.0mm透明角膜切口对2型糖尿病患者术后泪膜功能及眼表的影响。
　　方法：收集2015-01/10在我院接受超声乳化术的2型糖尿病患者150例150眼。按照随机数字表,将其分为两组,A组微切口组(75例75眼)行2.2mm透明角膜微切口白内障超声乳化术, B 组小切口组(75例75眼)行常规3.0 mm透明角膜切口白内障超声乳化术,两组资料的人口统计学特征差异无统计学意义。观察并比较两组患者术前及术后1wk,1、3、6mo的眼表疾病指数( ocular surface disease index,OSDI)、角膜知觉、泪膜破裂时间( break-up time,BUT)和基础泪液分泌试验( Schirmer’s Ⅰtest,SⅠt)指标的变化。
　　结果：术后1wk,1、3mo,两组患者的 OSDI 评分均高于术前,且B组的OSDI评分明显高于A组,差异有统计学意义(均P<0.05);两组患者的角膜知觉均较术前降低,且B组的角膜知觉明显低于A组,差异具有统计学意义(均P<0.05);两组患者的SⅠt均低于术前,且B组的SⅠt明显低于A组,差异具有统计学意义(均 P<0.05)。术后1wk,1mo,两组患者的BUT均低于术前,且B组的BUT明显低于A组,差异具有统计学意义(均 P<0.05)。术后6mo,A组患者的OSDI、角膜知觉、BUT和SⅠt与术前相比差异不明显,无统计学意义(均P>0.05);B组患者的OSDI评分和角膜知觉与术前相比差异明显,具有统计学意义(均P<0.05);BUT和SⅠt与术前相比差异不明显,无统计学意义(均P>0.05)。
　　结论：2.2mm透明角膜微切口对眼表及泪膜的影响较小,对并发白内障的2型糖尿病患者尤为适用。