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临床试验/NCT06656260
NCT06656260尚未招募不适用

Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study

IRCCS Ospedale San Raffaele0 个研究点目标入组 333 人开始时间: 2024年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
333
主要终点
The primary objective of the study is to validate the Italian version of the OSDI and OPAS questionnaires.

研究概览

简要总结

This study will be a single-center, observational, prospective validation study with survey and sample characteristics comparable to similar validation studies in the literature.

Pain represents a physiological response to the presence of tissue damage and is associated with numerous pathological conditions of the ocular surface.

Furthermore, in the presence of dysfunction of the nociceptive system, ocular pain can occur chronically with neuropathic features.

Pain quantification systems used to guide symptomatic therapy include the Ocular Surface Disease Index (OSDI); the Ocular Pain Assessment Survey (OPAS); and the Standardized Patient Evaluation of Eye Dryness (SPEED).

The OSDI assesses the presence of ocular symptoms, their impact on activities of daily living, and the presence of any aggravating factors. Although it is used in clinical practice and research activities in a translated version, it has never been validated in Italian.

The OPAS studies in more detail the characteristics of pain and associated symptoms and their impact on the patient's overall quality of life. This instrument has neither been translated nor validated in an Italian version.

The failure to validate the OSDI and OPAS questionnaires in the Italian version marks the starting point for this validative study.

The SPEED questionnaire, already translated and validated in Italian, will be used as the Gold Standard and will allow comparison of the other instruments.

Finally, six questions regarding imaginary scenarios of pain experiences will be proposed to assess the individual threshold of nociceptive sensitivity taken from the Pain Sensitivity Questionnaire (two for mild pain assessment, two for intermediate intensity stimuli, and two for intense pain situations).

Therefore, the primary objective of the study is to validate the Italian version of the OSDI and OPAS questionnaires while the secondary objective is to analyze the responses to the questionnaires by subgroups of general sensitivity to nociceptive stimuli.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The primary objective of the study is to validate the Italian version of the OSDI and OPAS questionnaires.

时间窗: The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point)

次要结局

  • Secondary objective is the analysis of questionnaire responses by subgroups of general sensitivity to nociceptive stimuli.(The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point))

研究者

发起方
IRCCS Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulio Ferrari

Professor of Ophthalmology-San Raffaele Vita Salute University, Cornea and Ocular Surface Unit; Head-Eye Repair Lab San Raffaele Scientific Institute

IRCCS Ospedale San Raffaele

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