The Comparison of 50 % Concentration Autologous Serum Eye Drops Versus Preservative Free Artificial Eye Drop Plus 0.05 % Cyclosporin Ophthalmic Emulsion in the Treatment of Severe Dry Eye Syndrome: A Randomized Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- tear break up time
研究概览
简要总结
The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE treatment in patients with severe DES
详细描述
This is an retrospective comparative study. The designation of the patient whether to use AS 8*1 or conventional PFAT 8*1 plus COE 2*1 was determined randomly. Student's paired samples t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U test were used to compare data. All patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment OSDI scores, Schirmer's test results, TBUT values, and OXFORD scale scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants chose their treatment regime randomly
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives)
- •had low TBUT (< 5 s) (5μL of fluorescein sodium 2% eye drops was used)
- •low Schirmer's test I score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the OXFORD Scale) (3) and an OSDI score > 40 OSDI was a reliable and valid test for quantifying the severity of dry eye symptoms
排除标准
- •active ocular infection or any other inflammation not associated with dry eye
- •a severe associated ocular allergy, eyelid or eyelash abnormality
- •current contact lens use, history of refractive surgery
- •associated glaucoma
- •current use of any type of topical eye drops other than dry eye medications
- •any known graft-versus host disease
- •known severe anemia (hemoglobin<11 g/dL-1)
- •medically uncontrolled significant cerebrovascular and cardiovascular disease
- •pregnant and lactating patients
研究组 & 干预措施
dry eye patients 1
dry eye patients treated for 1 month and patient symptoms after 1 month
干预措施: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 (Drug)
dry eye patients 1
dry eye patients treated for 1 month and patient symptoms after 1 month
干预措施: AS 50% eye drops 8*1 (Biological)
dry eye patients 2
dry eye patients treated for 1 month and patient symptoms after 1 month
干预措施: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 (Drug)
dry eye patients 2
dry eye patients treated for 1 month and patient symptoms after 1 month
干预措施: AS 50% eye drops 8*1 (Biological)
结局指标
主要结局
tear break up time
时间窗: first month results after two treatment regimes for severe dry eye groupes, dry eye quantitave assesment of tear break up time in seconds graded from 0 sec to 10 seconds 10 the best 0 the worst
clinical improvement in tear break up time
fluorescein staining of eye
时间窗: first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4
clinical improvement in fluorescein staining of eye
schirmers test 1 result
时间窗: first month results after two treatment regimes for severe dry eye groupes, 5 minutes tear drop wetness of schirmers paper in milimeters
clinical improvement in schirmer's test 1 result
ocular surface oxford scale
时间窗: first month results after two treatment regimes for severe dry eye groupes, dry eye symptom scale graded 1 to 4
clinical improvement in oxford scale
ocular surface disease index scale (OSDI)
时间窗: first month results after two treatment regimes for severe dry eye groupes, dry eye symptoms graduation prepared with sample questions concluded in 2 digit numbers from 25 to 100,
clinical improvement in OSDI
次要结局
未报告次要终点
研究者
Seref istek
Uşak University Training and Research Hospital, Department of Ophthalmology, Eye Clinic, Principal Investigator
Usak State Hospital