Comparison of Scleral Indentation Instruments and Impact on Patient Comfort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Pain scale
研究概览
简要总结
The scleral depression exam is an important routine technique for evaluating the retinal periphery for various reasons. During this examination, an instrument is used to bring the anterior part of the retina into the physician's field of view. The downside of this technique is the discomfort it may cause the patient. Different instruments can be used to depress the sclera.
The objective of this research is to compare three commonly used scleral depressors based on their performance for the ophthalmologist and the discomfort they subjectively induce in patients.
Patients will be randomly allocated to one of three examination groups:
Group A: One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor.
Group B: One eye examined with the Schocket scleral depressor, the other eye with the cotton-tip applicator.
Group C: One eye examined with the cotton-tip applicator, the other eye with the Josephberg-Besser scleral depressor.
详细描述
Background The scleral depression exam is an important technique for evaluating the retinal periphery during indirect ophthalmoscopy. Despite the advent of ultra-widefield fundus imaging, scleral depression provides greater sensitivity in detecting peripheral lesions, such as retinal tears. It was found that 11% of retinal tears were missed when employing non-contact slit-lamp examination, compared to indirect ophthalmoscopy with scleral depression, and a scleral depression exam is widely considered the gold standard for ruling out retinal tears. While there is no international consensus, the preferred practice guideline (American Academy of Ophthalmology) for assessing peripheral vitreoretinal pathology is by indirect ophthalmoscopy combined with scleral depression.
There are a variety of ophthalmic instruments that an eye care professional may use to perform scleral depression. While the exam is uncomfortable, there is a lack of studies comparing patient comfort with different instruments. In this prospective study, we will compare subjective patient pain scores using the Schocket scleral depressor, the Josephberg-Besser scleral depressor, and the cotton-tipped applicator.
Purpose To assess patient pain scores for three common scleral indentation devices and determine which is most comfortable for patients.
Objective / Hypothesis Based on clinical experience, the hypothesis is that the Josephberg-Besser scleral depressor causes less discomfort due to its design.
Study Design Prospective comparative analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic posterior vitreous detachment with or without vitreoretinal pathology
排除标准
- •Monocular status.
- •Media opacity which precludes view of the peripheral retina.
- •Inadequate examination (cooperation with examination, inability to achieve all directions of gaze).
- •Underlying oculodynia (recent surgery, intraocular inflammation, abnormal intraocular pressure, ocular dysesthesia syndromes (ocular, adnexal or orbital).
- •History of pain-sensitizing conditions or current analgesic use.
- •Previous scleral indented examination poorly tolerated.
研究组 & 干预措施
Group A
One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor
干预措施: Josephberg-Besser (Diagnostic Test)
Group B
One eye examined with the Schocket scleral depressor, the other eye with the cotton tip applicator
干预措施: Schocket scleral depressor (Diagnostic Test)
Group B
One eye examined with the Schocket scleral depressor, the other eye with the cotton tip applicator
干预措施: Cotton tip applicator (Diagnostic Test)
Group C
One eye examined with the cotton tip applicator, the other eye with the Josephberg-Besser scleral depressor
干预措施: Josephberg-Besser (Diagnostic Test)
Group C
One eye examined with the cotton tip applicator, the other eye with the Josephberg-Besser scleral depressor
干预措施: Cotton tip applicator (Diagnostic Test)
Group A
One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor
干预措施: Schocket scleral depressor (Diagnostic Test)
结局指标
主要结局
Pain scale
时间窗: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Patient rate their pain with the Wong-Baker Faces scale for each eye, from 0 to 10, 0 being the absence of pain and 10 being the worst imaginable pain.
次要结局
- Ergonomics Ease of use(Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.)
- Performance accessing the visualized area(Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.)
- Quantity of indentation(Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.)
- Performance achieving sufficient indentation(Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.)
- Duration of examination(Time mesure will be during the examination of each eye)
- Degree of retinal pathology(The physician will note his findings right after his examination, while completing his examination survey)