Paralysis of the Orbicularis Muscle of the Eye by Using Botulinum Toxin Type A in the Treatment for Dry Eye
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Visual acuity (Snellen vision acuity)
研究概览
简要总结
This is a prospective, comparative, contralateral eye study. Patients older than 18 years who have had treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein were included. Patients with dry eye attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal infection, as well as patients with severe dry eye were excluded from the study. One eye randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower eyelid, and the other eye received a similar procedure with placebo. The subjective evaluation was achieved with a questionnaire assessing symptoms of dry eye and conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective evaluation included the measurement of the tear film break up time, Schirmer's test and with a modification of the Oxford grading scheme for corneal and conjunctival staining.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein.
排除标准
- •Dry eye patients attributable to abnormalities of the eyelids (problems with the mechanism of blinking, poor eyelid position, changes in position or structure of the eyelashes, high surface lesions, etc.)
- •Nasolacrimal obstruction.
- •Active corneal infection.
- •Patients with severe grade 4 dry eye.
研究组 & 干预措施
Sham injection
An injection of 4 international units of sham will be applied in the medial in the medial part of the lower eyelid near the punctum directed along the medial canthal tendon in a single application by subcutaneous injection.
干预措施: Saline solution injection (Other)
Botulinum toxin type A injection
An injection of 4 international units of botulinum toxin type A will be applied in the medial in the medial part of the lower eyelid near the punctum directed along the medial canthal tendon in a single application by subcutaneous injection.
干预措施: Botulinum toxin type A injection (Drug)
结局指标
主要结局
Visual acuity (Snellen vision acuity)
时间窗: 6 months
Snellen vision acuity
Symptoms of conjunctivitis (questionnaire)
时间窗: 6 months
A questionnaire assessing symptoms of conjunctivitis eye separately, including redness and discharge. Depending on the frequency, each symptom will be graded from 0 to 5.
Quality of vision (graded perception of patient)
时间窗: 6 months
The quality of vision will be graded from 0 to 5 according to the perception of the patient.
Moisturizing agent usage (patient will be asked how many times a day does he use the moisturizing agent and will be graded from 0 to 5 according to the frequency)
时间窗: 6 months
The
Measurement of the tear film break up time (After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking)
时间窗: 6 months
After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking will be recorded in seconds.
Oxford grading scheme for corneal and conjunctival staining
时间窗: 6 months
After fluorescein staining, the corneal and conjunctival staining will be graded according to severity from 0 to 5.
Ocular comfort level (graded perception of patient)
时间窗: 6 months
The ocular comfort level will be graded from 0 to 5 according to the perception of the patient.
Schirmer's test
时间窗: 6 months
After instillation of topical anesthetic, paper strips are inserted into the conjunctival sac for 5 minutes to measure the production of tears in millimeters.
Symptoms of dry eye (questionnaire)
时间窗: 6 months
A questionnaire assessing symptoms of dry eye each eye separately, including dryness, watery eyes, itching, burning, foreign body, fluctuating vision and light sensitivity. Depending on the frequency, each symptom will be graded from 0 to 5.
次要结局
未报告次要终点