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

October 21, 2024 updated by: Giulio Ferrari, IRCCS Ospedale San Raffaele

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A cohort of patients with corneal and ocular surface diseases referred to the Ophthalmology O.U. - Cornea Center of IRCCS Ospedale San Raffaele will be studied.

Description

Inclusion Criteria:

  • NA

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QDO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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