Effect of oxybuprocaine 0.4% in preventing surgically induced miosis.

In a group of 68 patients a double-blind study was performed to assess the effect of preoperative oxybuprocaine 0.4% (Dorsacaine, Novesin) eye drops in comparison with a placebo in preventing surgically induced miosis during extracapsular cataract extraction. One drop of oxybuprocaine 0.4% or placebo was instilled 10 and 5 minutes preoperatively. The pupil diameter was recorded at different stages of the operation. It was found that oxybuprocaine reduced the amount of pupil constriction during the operation significantly as compared with the placebo group, facilitating the removal of lens material and the implantation of an intraocular lens. The effect of oxybuprocaine is considered to be due to anaesthetic action on sensory nerves in the eye, which may inhibit the release of a miotic substance.     

2%双醋瑞因滴眼液结膜囊多次与单次给药的角膜药代动力学差异

目的：对比2%双醋瑞因滴眼液结膜囊多次给药与单次给药在角膜中的药代动力学差异,为临床医师治疗感染性角膜病时多次给药提供实验依据。

方法：以2%双醋瑞因为实验滴眼液,选取健康无眼疾的雄性昆明白小鼠,随机分为多次给药组和单次给药组,双眼结膜囊分别给予双醋瑞因滴眼液。多次给药组间隔2min给药一次,共给药3次; 单次给药组仅给药1次。用高效液相法测定角膜中双醋瑞因的代谢产物(大黄酸)的浓度,多次给药组和单次给药组的时间点均为5、15、30、60、120、180min。将小鼠角膜组织中的药物浓度经药物动力学程序(DAS2.1.1)进行拟合,并计算相关药动学参数。

结果：结膜囊多次给药组和单次给药组各个时间点角膜中均可检测到其活性代谢产物大黄酸; 多次给药组5、15、30、60、120、180min的浓度分别为318.678±40.88、210.02±25.66、188.83±31.74、112.24±11.70、90.28±22.01和57.67±13.71μg/g,单次给药组各时间点浓度分别为145.17±19.29、97.95±10.49、71.18±18.70、39.11±2.44、18.10±2.34和9.08±2.04μg/g。两组小鼠角膜中大黄酸的含量均于给药后5min最高,多次给药组浓度高于单次给药组浓度,差异具有统计学意义(P<0.01)。随时间延长大黄酸的浓度逐渐下降,3h后多次给药组浓度仍高于单次给药组,差异具有统计学意义(P<0.01)。单次给药组半衰期为0.89±0.31h。

结论：结膜囊多次给药与单次给药相比具有药物有效浓度高、维持时间长的优点,双醋瑞因作为一种新的抗菌药物,可以在感染性角膜炎的早期对病程的发展起到抑制作用。多次给药后可以对急性发展期起到较好的治疗效果,而且在夜晚也可维持较高浓度,在保证患者的睡眠休息质量同时又起到了对疾病的治疗作用。     

Corneal thickness and endothelial density before and after cataract surgery

BACKGROUND/AIMS—Deturgescence of the corneal stroma is controlled by the pumping action of the endothelial layer and can be monitored by measurement of central corneal thickness (pachymetry). Loss or damage of endothelial cells leads to an increase in corneal thickness, which may ultimately induce corneal decompensation and loss of vision. Little is known about the effect of moderate reductions in endothelial cell number on the thickness of the corneal stroma. This study aimed to investigate this matter further using patients who had incurred moderate decreases in their endothelial cell counts as a result of cataract surgery.
METHODS—Central corneal thickness was measured 1 day before surgery, 1 day after surgery, and again at 3 months or 1 year. Endothelial cell counts were also performed 1 day before surgery and thereafter at 3 months or 1 year after surgery. The relationship between these two parameters was assessed statistically. Precise measurements of central corneal thickness were made by optical low coherence reflectometry. For comparative purposes, this parameter was also determined by ultrasonic pachymetry. Central corneal endothelial cell numerical density was estimated on photomicrographs taken with a specular microscope.
RESULTS—All patients had significant postoperative corneal swelling on the day after surgery; preoperative values were restored by 3 and 12 months, even though significant endothelial cell losses had occurred. No correlation existed between central corneal thickness and central corneal endothelial cell numerical density. Measurements estimated by ultrasonic pachymetry were more variable and significantly higher than those determined by optical low coherence reflectometry.
CONCLUSION—As long as the numerical density of the corneal endothelial cells does not fall below the physiological threshold, a moderate decrease in this parameter does not compromise the pumping activity of the layer as a whole.

     

Corneal epithelial barrier function after oxybuprocaine provocation in diabetics

Corneal epithelial permeability for fluorescein was determined after provocation by a local anesthetic in 18 non-insulin-dependent diabetes mellitus (NIDDM) patients, 23 insulin-dependent diabetes mellitus (IDDM) patients, and 22 healthy controls to evaluate the corneal epithelial barrier function in diabetes. All volunteers had Oxybuprocaine instilled into one eye and saline into the other eye. The epithelial permeability values were determined by fluorophotometry, and the ratio between both eyes was calculated for each individual. The mean permeability values of the saline-instilled eyes in the diabetic patients did not differ significantly from those in the healthy controls (P greater than 0.2). The individual ratios between Oxybuprocaine- and saline-instilled eyes in the NIDDM and IDDM patients differed significantly from those in the healthy controls (mean ratios: 2.6, 1.9, and 1.0, respectively; P less than 0.002). The permeability ratios and the percentage glycosylated hemoglobin (HbAlc) were linearly correlated in the NIDDM patients but not in the IDDM patients (r = 0.73, P less than 0.001, and r = 0.09, P greater than 0.68, respectively). The results showed that the corneal epithelial barrier function in the diabetic patients was not impaired compared with that in the healthy controls. After provocation by a local anesthetic, the barrier function was impaired in the diabetic patients only.     

Atenolol 4 % eye drops and glaucoma

Summary We studied the effect of a single dose of atenolol 4% eye drops on 21 patients with primary open-angle glaucoma during a double-blind clinical trial. We monitored intraocular pressure (IOP), blood pressure, and pulse rate. At three and six h after medication, the average reduction of IOP was 7.3 and 4.1 mm Hg, respectively, compared to the baseline readings without medication. The reduction of IOP at four h after medication was 6.3 mm Hg compared to the pretreatment value. This corresponds to an average change from the pretreatment value of 22 percent. Blood pressure and pulse rate did not change significantly. We observed no subjective or objective ocular side effects. The duration of the effect of a single dose of atenolol 4% eye drops is approximately six h. Atenolol 4% eye drops may become a useful agent in the medical treatment of glaucoma if a long-term effect and no ocular side effects (especially a local anesthetic effect) can be proven.

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Zusammenfassung Wir prüften die Wirkung einer Einzeldosis Atenolol 4% Augentropfen bei 21 Patienten mit Glaukom mit weitem Kammerwinkel im Doppelblindversuch. Wir kontrollierten den Augeninnendruck, Blutdruck und Puls. Drei und sechs Stunden nach dem Eintropfen betrug die mittlere Drucksenkung 7.3 bzw. 4.1 mm Hg im Vergleich zu den Werten ohne Therapie. Die Drucksenkung vier Stunden nach dem Eintropfen betrug 6.3 mm Hg im Vergleich zum Wert vor dem Eintropfen. Dies stimmt überein mit 22 Prozent mittlerer Abweichung vom Druck vor dem Eintropfen. Blutdruck und Puls änderten sich nicht signifikant. Objektive oder subjektive Nebenwirkungen waren nicht nachweisbar. Die Wirkungsdauer einer Einzeldosis Atenolol 4% beträgt etwa sechs Stunden. Atenolol 4% Augentropfen könnten sich als ein nützlicher Zusatz zur medikamentösen Glaukomtherapie erweisen, falls auch in der Dauerprüfung keine Nebenwirkungen am Auge (besonders lokal-anästhetische Effekte) nachweisbar sind.

     

Corneal thickness in trachomatous dry eye

PURPOSE: To investigate the effect of severe desiccation on corneal thickness in scarring trachoma by comparing the thickness of normal and trachomatous dry eye corneas. METHODS: Ultrasonic pachymetry was used to measure the corneal thickness at nine points in the central and peripheral cornea (superior, superonasal, nasal, inferonasal, inferior, inferotemporal, temporal, superotemporal) in 45 eyes of 27 patients with trachomatous dry eye and 54 eyes of 31 normal subjects. RESULTS: The average thickness of the nine sites in the central and midperipheral cornea was significantly less in trachomatous dry eyes than normal eyes. The superior cornea was the thickest area in both groups, measuring 574.03+/-31.62 microm in trachomatous dry eyes and 611.33+/-34.99 microm in normal eyes (p<0.001). The centre of the cornea was the thinnest, measuring 510.43+/-32.12 microm in trachomatous dry eyes and 546.27+/-36.20 microm in normal eyes (p<0.001). CONCLUSIONS: The thickness of the central and midperipheral cornea was significantly reduced in patients with trachomatous dry eye. The chronic state of severe desiccation, tear film instability and increased immune activation in trachomatous dry eye may contribute to this thinning.     

Efficacy and safety of indomethacin 0.1% eye drops compared with ketorolac 0.5% eye drops in the management of ocular inflammation after cataract surgery

Purpose: To determine whether indomethacin 0.1% eye drops are at least as effective as ketorolac 0.5% eye drops in treating ocular inflammation following cataract surgery. Methods: Prospective, multicenter, investigator‐masked, parallel‐group, randomized, active‐controlled clinical trial. Cataract patients were randomized in a 1:1 ratio to receive indomethacin or ketorolac administered QID for 3 weeks beginning 1 day before surgery. The primary end‐point was aqueous flare measured by laser flare meter at postoperative Days 1 and 7. Secondary end‐points included retinal thickness, slit lamp and funduscopic examinations and postsurgical pain ratings. Safety and tolerability were also assessed. Results: A total of 86 patients were included in the per protocol population (n = 43 per treatment group). Indomethacin was found non‐inferior to ketorolac for comparison of aqueous flare at postoperative Days 1 and 7 (Day 1: 95% CI: ?2.37, 5.50; non‐inferiority upper margin, 15 ph/ms and Day 7: 95% CI: ?7.83, ?0.94; non‐inferiority upper margin, 8 ph/ms) and statistically better than ketorolac at Day 7 (p = 0.013). There were no significant between‐group differences in aqueous flare and change from baseline in retinal thickness at postoperative Days 30 and 90. Indomethacin showed a higher subjective tolerance rating than ketorolac at postoperative Days 7 and 30 (p ≤ 0.044). Conclusion: Indomethacin 0.1% was at least as effective as ketorolac 0.5% at Day 1 and more effective than ketorolac 0.5% at Day 7 in treating ocular inflammation after uncomplicated cataract surgery. Indomethacin was better tolerated than ketorolac. There were no clinically meaningful safety concerns with either treatment.     

Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eye drops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis

PURPOSE: The efficacy and safety of emedastine 0.05% eye drops (Emadine; Alcon Laboratories, Inc, Fort Worth, Texas), a new H(1) antagonist, were studied in comparison to levocabastine 0.05% eye drops (Livostin; Janssen-Cilag N V, Berchem, Belgium) during a twice-daily treatment schedule for 6 weeks in adult and pediatric patients with seasonal allergic conjunctivitis. METHODS: In a prospective, multicenter, randomized, double-masked, parallel group study, 222 patients with allergic conjunctivitis were randomized (221 received treatment) to either emedastine or levocabastine, instilled twice daily for 6 weeks. Patient diaries were completed four times daily (before the morning and evening instillations, at noon, and in the afternoon), and clinical examinations were conducted at regular intervals. Primary efficacy variables of ocular redness and itching and secondary efficacy variables of chemosis, eyelid swelling, patient diary data, and physician's global assessment were analyzed. RESULTS: Both emedastine and levocabastine produced a statistically significant (P =.0001) reduction in itching and redness within 5 minutes of the first instillation. All signs and symptoms improved progressively over the 6-week treatment period. After 7 days of use, and throughout the remainder of the study, emedastine was statistically superior to levocabastine (P <.006) in preventing and alleviating the signs and symptoms (itching, redness, chemosis, and eyelid swelling) of allergic conjunctivitis. CONCLUSIONS: Emedastine 0.05% eye drops administered twice daily are more efficacious than levocabastine 0.05% eye drops in the prevention and treatment of the signs and symptoms of allergic conjunctivitis in adults and children of 4 years and above. Both emedastine 0.05% eye drops and levocabastine 0.05% eye drops were well tolerated.     

术前常用滴眼液对角膜内皮及角膜厚度的影响

目的 讨论白内障手术前常规使用的左氧氟沙星滴眼液、妥布霉素滴眼液及普拉洛芬滴眼液滴眼对角膜内皮细胞密度及角膜厚度的影响.方法 白内障手术前120例(120眼),随机分为6个组.术前分别以4次/d及1次/h两种频率滴用左氧氟沙星滴眼液、妥布霉素滴眼液及普拉洛芬滴眼液连续3d,检测用药前后角膜内皮细胞密度及角膜厚度.结果 3种滴眼液按照两种使用频率连用3d,用药前后角膜内皮细胞密度及中央角膜厚度自身对照比较差异均无统计学意义(t=- 1.595～1.608,P＞O.05).结论 左氧氟沙星、妥布霉素及普拉洛芬滴眼液对角膜内皮细胞密度及角膜厚度的并无明显影响.     

青光眼手术前后双氯灭痛滴眼液的作用

目的：观察双氯灭痛滴眼液在青光眼手术中的抗炎作用。方法：53例（99眼）青光眼随机分成2组，治疗组53眼，对照组46眼。治疗组手术前后使用0．1％双氯灭痛滴眼液，对照组不同。结果：治疗组术后平均视力较术前提高，而对照组视力较术前下降；治疗组术后前房渗出及晶状体前囊色素沉着明显少于对照组；术后眼内反应轻。结论：双氯灭痛滴眼液可减轻青光眼手术后的眼内炎症反应。     

Corneal thickness is reduced in dry eye.

PURPOSE: To evaluate and compare corneal thickness in normal and dry eyes. METHODS: The Orbscan corneal topography system was used to measure the corneal thickness at nine locations in the central and peripheral (superior, superonasal, nasal, inferonasal, inferior, inferotemporal, temporal, superotemporal) cornea in 38 eyes of 21 patients with aqueous tear deficiency dry eye and 34 eyes of 21 normal subjects. RESULTS: The average thickness of nine sites in the central and midperipheral cornea was significantly decreased in dry eyes compared with that of normal eyes. The superior cornea was found to be the thickest area in both groups, measuring 0.629 +/- 0.030 mm in normal eyes and 0.589 +/- 0.031 mm in dry eyes. The center of the cornea was noted to be the thinnest in both groups, measuring 0.571 +/- 0.028 mm and 0.534 +/- 0.034 mm in normal and dry eyes, respectively. In color-coded pachymetry maps, the oval pattern was observed in 67.6% of normal corneas and 39.5% of dry eyes, while the decentered oval pattern was noted in 2.9% and 31.6% of normal and dry eyes, respectively (p < 0.025 for oval pattern and p < 0.005 for decentered oval map). The mean astigmatism was 0.99 +/- 0.43 diopter (D) in normal corneas and 1.42 +/- 0.92 D in dry eyes (p = 0.015). In the anterior elevation maps, the island pattern was the most commonly observed pattern in both groups, 88.3% in normal corneas and 60.5% in dry eyes (p < 0.01). No significant difference in the patterns of posterior corneal elevation maps and axial power maps of the anterior corneal surface was noted between groups. CONCLUSION: The corneal thickness of the central and midperipheral cornea was significantly decreased in the dry eyes. It is possible that the chronic state of desiccation and immune activation in dry eye may contribute to the observed corneal thinning. Perhaps the frank corneal ulceration that occurs in some dry eyes is a more severe manifestation of this phenomenon.     

Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis

PURPOSE: To compare the safety and tolerability of 1.0% azithromycin in a polymeric mucoadhesive delivery system with 0.3% tobramycin ophthalmic solution for the treatment of bacterial conjunctivitis. METHODS: This study was a prospective, randomized, active-controlled, double-masked, phase 3 trial conducted from August 6, 2004, to October 6, 2005, at 47 sites. Subjects with a clinical diagnosis of bacterial conjunctivitis were randomly assigned to receive either 1% azithromycin in DuraSite (AzaSite; InSite Vision, Alameda, CA) (n = 365) or 0.3% tobramycin (n = 378). Both groups received masked medication four times daily for 5 days, but participants received an active dose of 1% azithromycin in DuraSite only twice a day on days 1 and 2 and daily on days 3 to 5. Conjunctival cultures were taken, and ocular signs and symptoms were evaluated at baseline and at two follow-up visits. RESULTS: A total of 743 patients were randomized, and 710 (96%) completed the trial. Both study medications were well tolerated. The most frequently observed ocular adverse events in the azithromycin group were eye irritation (1.9%), conjunctival hyperemia (1.1%), and worsening bacterial conjunctivitis (1.1%). These rates compared favorably with those obtained with tobramycin. Rates of microbial eradication (an efficacy parameter) and bacterial infection recurrence (a safety parameter) were the same in both groups. CONCLUSIONS: This is the first report of the safety and tolerability of a commercially manufactured preparation of azithromycin for ophthalmic use. Azithromycin 1% in DuraSite is safe and can be administered in a regimen of less frequent doses than can tobramycin, while producing an equivalent clinical outcome. The formulation is well tolerated in patients over the age of 1 year for the eradication of bacteria commonly associated with conjunctivitis. (ClinicalTrials.gov number, NCT00105469.).     

Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops

PURPOSE: To assess the efficacy of lidocaine gel, bupivacaine drops, and benoxinate drops as topical anesthetic agents in cataract surgery. SETTING: Kasr El-Aini Hospital, Cairo University, Cairo, Egypt. METHODS: This prospective randomized study comprised 90 patients scheduled for routine cataract extraction. Patients were randomized into 3 groups of 30 each based on which anesthetic agent they received: lidocaine 2% gel, bupivacaine 0.5% drops, or benoxinate 0.4% drops. Subjective pain at application of the agent and intraoperatively was quantified by the patients using a verbal pain score (VPS) scale from 0 to 10. The duration of discomfort at application, duration of surgery, rate of supplemental sub-Tenon's anesthesia, and complications were recorded. RESULTS: The mean VPS at application was 2.97, 1.53, and 1.03 in the lidocaine, bupivacaine, and benoxinate groups, respectively; the VPS in the lidocaine group was statistically significantly higher than in the other 2 groups (P<.001). The mean duration of pain at application was 25 seconds, 14 seconds, and 6 seconds in the lidocaine, bupivacaine, and benoxinate groups, respectively, and was statistically significantly higher in the lidocaine group (P<.001). The mean VPS during surgery was 1.6, 4.1, and 7.1 in the lidocaine, bupivacaine, and benoxinate groups; the lidocaine group had a statistically significantly lower mean VPS than the other 2 groups (P<.001). The incidence of supplemental sub-Tenon's injection was 3.3%, 10.0%, and 73.3%, respectively, and was statistically significantly lower in the lidocaine and bupivacaine groups than in the benoxinate group (P<.001). The patients' overall satisfaction was statistically significantly higher in the lidocaine and bupivacaine groups than in the benoxinate group (93.3%, 83.3%, and 33.3%, respectively) (P<.001). Three patients in the lidocaine group had corneal haze at the time of surgery, which was not statistically significant (P>.1). CONCLUSIONS: Lidocaine gel was a better topical anesthetic agent than bupivacaine and benoxinate drops. Bupivacaine drops were effective in providing deep topical anesthesia.     

Autologous serum eye drops for dry eye after LASIK

PURPOSE: To evaluate the efficacy of autologous serum eye drops for dry eye after LASIK in a prospective, randomized study. METHODS: Fifty-four eyes of 27 male patients who underwent LASIK were divided into two groups; patients who used autologous serum eye drops and those who used artificial tears postoperatively. Schirmer test with anesthesia, tear break-up time (BUT), and rose bengal and fluorescein staining for the ocular surface were prospectively compared between the groups. All values were also compared before and after surgery (at 1 week [except for Schirmer test], 1 month, 3 months, and 6 months) in each group. RESULTS: Tear BUT was greater in the autologous serum eye drops group than in the artificial tears group at 6 months postoperatively. Rose bengal score was lower in patients using autologous serum eye drops than in patients using artificial tears at 1 month and 3 months postoperatively. No significant difference was noted between patients using autologous serum eye drops and patients using artificial tears in the value of Schirmer test with anesthesia and fluorescein scores. In the autologous serum eye drops group, tear BUT was increased at 3 months after LASIK, rose bengal score was lower at 1 month and 3 months, and fluorescein score was lower at 1 month after LASIK compared to preoperative values, respectively. In the artificial tears group, all values (Schirmer test, tear BUT, rose bengal score, and fluorescein score) showed no differences between before and after LASIK. No differences were noted in the subjective scores for dryness between the autologous serum eye drops and artificial tears groups. CONCLUSIONS: The autologous serum eye drops group showed prolongation of the tear BUT and a reduction in rose bengal staining score.     

LASIK术后角膜知觉的变化及干眼的发生

目的：探讨准分子激光原位角膜磨镶术（LASIK）后角膜知觉的变化及其对干眼的影响与切削深度的关系。 方法：观察上方蒂做瓣的LASIK手术30例（60眼），观察指标包括患者术中切削深度及术前，术后1wk，lmo，3mo的角膜中央知觉、基础泪液分泌量、泪膜破裂时间（BUT）、角膜荧光素钠染色评分、干眼主觉症状评分。 结果：术后1wk，1mo角膜知觉敏感度与术前相比差异均非常显著（P〈0．01），术后3mo平与术前相比差异无统计学意义（P〉0．05）；术后1wk患者的主觉症状与术前相比无显著差异（P=0．079〉0．05），术后mo时差异显著（P=0．025〈0．05），术后3mo时差异极其显著（P=0．001〈0．01）；患者术后泪流量在术后1wk：1mo时明显低于术前（P〈0．01），直至术后3mo仍未恢复至术前水平（P〈0．01）；术后1wk，1mo，3mo泪膜破裂时间缩短，术后3mo时与术前相比差异显著（P〈0．01）；角膜荧光素钠染色评分方面，术后1mo时角膜上皮损伤最明显，术后3㈤时与术前仍有显著差异（P〈0．01）直线回归与相关分析结果，说明在两者之间存在直线相关的关系r=0．798，P〈0．01。 结论：LASIK术后角膜中央知觉明显下降并随时间延续而逐渐恢复，3mo时与术前无统计学差异；但是干眼的相关指标并未随之恢复至术前水平；术后角膜知觉的下降与术中切削深度间存在正相关。