Ocular PainNCT06656260
Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study
An observational study of Ocular Pain and OSDI, run by IRCCS Ospedale San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Pain, OSDI, OPAS
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- NA
Who cannot join
- NA
Trial locations and contacts
No sites are listed yet.
About this 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.
Read more
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.
- Conditions
- Ocular Pain, OSDI, OPAS
- Keywords
- Ocular pain, OSDI, OPAS, Questionnaire
- Medical subject headings
- Eye Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to validate the Italian version of the OSDI and OPAS questionnaires.
Measured: 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.
Measured: The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Ferrari, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656260
- Sponsor's protocol ID
- QDO
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06656260
- Acronym / sponsor ID
- QDO
- Conditions
- Ocular Pain, OSDI, OPAS
- Keywords
- Ocular pain, OSDI, OPAS, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- NA
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Pain and OSDI, run by IRCCS Ospedale San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulio Ferrari, Medical Doctor (+39 0226436186, ferrari.giulio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.