Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-04 @ 5:54 AM
Study NCT ID:
NCT06656260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study
Sponsor:
IRCCS Ospedale San Raffaele
Organization:
Study Overview
Official Title:
Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: