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NCT Number: NCT06656260

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NA

Exclusion criteria

  • NA

Treatment and study plan

Primary outcomes

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

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

Secondary outcomes

  1. Secondary objective is the analysis of questionnaire responses by subgroups of general sensitivity to nociceptive stimuli.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giulio Ferrari, Medical Doctor

CONTACT

[email protected]

+39 0226436186

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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