Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 10:18 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058447', 'term': 'Eye Pain'}], 'ancestors': [{'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 333}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of the study is to validate the Italian version of the OSDI and OPAS questionnaires.', 'timeFrame': 'The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point)'}], 'secondaryOutcomes': [{'measure': 'Secondary objective is the analysis of questionnaire responses by subgroups of general sensitivity to nociceptive stimuli.', 'timeFrame': 'The questionnaire will be acquired at day 0 (first time-point) and at day 7 (second time-point)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ocular pain', 'OSDI', 'OPAS', 'Questionnaire'], 'conditions': ['Ocular Pain', 'OSDI', 'OPAS']}, 'descriptionModule': {'briefSummary': "This study will be a single-center, observational, prospective validation study with survey and sample characteristics comparable to similar validation studies in the literature.\n\nPain represents a physiological response to the presence of tissue damage and is associated with numerous pathological conditions of the ocular surface.\n\nFurthermore, in the presence of dysfunction of the nociceptive system, ocular pain can occur chronically with neuropathic features.\n\nPain 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).\n\nThe 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.\n\nThe 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.\n\nThe failure to validate the OSDI and OPAS questionnaires in the Italian version marks the starting point for this validative study.\n\nThe SPEED questionnaire, already translated and validated in Italian, will be used as the Gold Standard and will allow comparison of the other instruments.\n\nFinally, 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).\n\nTherefore, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NA\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT06656260', 'briefTitle': 'Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Ospedale San Raffaele'}, 'officialTitle': 'Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'QDO'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Giulio Ferrari, Medical Doctor', 'role': 'CONTACT', 'email': 'ferrari.giulio@hsr.it', 'phone': '+39 0226436186'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Ospedale San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology-San Raffaele Vita Salute University, Cornea and Ocular Surface Unit; Head-Eye Repair Lab San Raffaele Scientific Institute', 'investigatorFullName': 'Giulio Ferrari', 'investigatorAffiliation': 'IRCCS Ospedale San Raffaele'}}}}