Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-30 @ 1:57 PM
Study NCT ID:
NCT06979557
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RLE Outcomes With Bilateral Implantation of Odyssey IOLs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of patients within ± 0.5 D MRSE', 'timeFrame': '2 months posoperatively', 'description': 'Manifest refraction spherical equivalent (MRSE)'}, {'measure': 'Percentage of eyes requiring additional corneal refractive procedures', 'timeFrame': '2 months postoperative'}, {'measure': 'Correlation between pupil size and defocus curve', 'timeFrame': '2 months postoperative'}], 'primaryOutcomes': [{'measure': 'Binocular Photopic Visual Acuity', 'timeFrame': '2 months posoperatively', 'description': 'Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.'}, {'measure': 'Monocular Photopic Visual Acuity', 'timeFrame': '2 months posoperatively', 'description': 'Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.'}, {'measure': 'Monocular Defocus Curve (right eye only)', 'timeFrame': '2 months posoperatively'}, {'measure': 'Binocular Defocus Curve', 'timeFrame': '2 months posoperatively'}], 'secondaryOutcomes': [{'measure': 'Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire', 'timeFrame': '2 months posoperatively', 'description': 'The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Lower scores for the symptom questions indicate lower frequency and both of visual disturbances.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Lens Exchange']}, 'descriptionModule': {'briefSummary': 'This study is a single center, ambispective study of visual outcomes after successful bilateral implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS questionnaire, as well as measurement of visual acuities at distance, intermediate, and near, monocular (right eye) and binocular defocus curve, and refractive outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will include 40 patients aged 40 years and older who have a measurable Potential Acuity Meter (PAM) of 20/20 electing to undergo bilateral refractive lensectomy surgery with IOL implantation.\n\nExclusion Criteria:\n\n* Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.'}, 'identificationModule': {'nctId': 'NCT06979557', 'briefTitle': 'RLE Outcomes With Bilateral Implantation of Odyssey IOLs', 'organization': {'class': 'OTHER', 'fullName': 'Mann Eye Institute'}, 'officialTitle': 'Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses', 'orgStudyIdInfo': {'id': 'PB-25-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Odyssey IOL', 'description': 'Bilateral Implantation with the Odyssey IOL', 'interventionNames': ['Device: Odyssey IOL']}], 'interventions': [{'name': 'Odyssey IOL', 'type': 'DEVICE', 'description': 'Bilateral implantation with the Odyssey IOL', 'armGroupLabels': ['Odyssey IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134-2099', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Hamann Wright', 'role': 'CONTACT', 'email': 'Melissa.Wright@manneye.com', 'phone': '713-580-2500', 'phoneExt': '2389'}, {'name': 'Phillip Brunson, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mann Eye Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Melissa Hamann Wright', 'role': 'CONTACT', 'email': 'melissa.wright@manneye.com', 'phone': '832-368-0117'}], 'overallOfficials': [{'name': 'Phillip Brunson, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mann Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mann Eye Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}