Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05716269
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2023-01-22', 'studyFirstSubmitQcDate': '2023-02-04', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected distance visual acuity of the operated eye', 'timeFrame': '3 months postoperatively', 'description': 'Best corrected distance visual acuity (BCDVA) of the operated eye will be measured.'}], 'secondaryOutcomes': [{'measure': 'Uncorrected distance visual acuity (UCVA)', 'timeFrame': '3 months postoperatively', 'description': 'Uncorrected distance visual acuity (UCVA) of the operated eye will be measured at 5m.'}, {'measure': 'Uncorrected intermediate visual acuity', 'timeFrame': '3 months postoperatively', 'description': 'Uncorrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.'}, {'measure': 'Uncorrected near visual acuity', 'timeFrame': '3 months postoperatively', 'description': 'Uncorrected near visual acuity of the operated eye will be measured at 40cm.'}, {'measure': 'Best corrected intermediate visual acuity', 'timeFrame': '3 months postoperatively', 'description': 'Best corrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.'}, {'measure': 'Best corrected near visual acuity', 'timeFrame': '3 months postoperatively', 'description': 'Best corrected near visual acuity of the operated eye will be measured at 40cm.'}, {'measure': 'Manifest refraction spherical equivalent', 'timeFrame': '3 months postoperatively', 'description': 'Manifest refraction spherical equivalent of the operated eye will be measured'}, {'measure': 'Visual disturbance, spectacle independence and patient satisfaction', 'timeFrame': '3 months postoperatively', 'description': 'A questionnaire including visual disturbance, spectacle independence and patient satisfaction will be distributed to subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'To evaluate visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients', 'detailedDescription': 'Patients with axial length ≤22.5mm will be recruited. The subjects will undergo bilateral uneventful phacoemulsification and implantation of PanOptix. Visual quality and patients satisfactory will be assessed three months after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hyperopic cataract patients receiving bilateral uneventful phacoemulsification and implantation of PanOptix.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age-related cataract patients\n\n * Eye axis length ≤22.5mm and refraction ≥ +0.5D\n * Predicted postoperative corneal astigmatism ≤0.75D\n * mesopic pupil size between 3.0mm to 5.5 mm\n * Preoperative angle kappa ≤ 0.5 mm\n * Preoperative corneal spherical aberration \\<0.5μm, high order aberration \\<0.5μm\n\nExclusion Criteria:\n\n* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)\n* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)\n* History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis\n* Patients with history of ocular trauma or prior ocular surgery including refractive procedures\n* Preoperative visual acuity of worse than 0.2 logMAR in any eye.'}, 'identificationModule': {'nctId': 'NCT05716269', 'briefTitle': 'Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Evaluation of Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients: a Prospective, Cohort Study', 'orgStudyIdInfo': {'id': '2022756'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hong Qi, MD, PhD', 'role': 'CONTACT', 'email': 'doctorqihong@163.com', 'phone': '13901066889'}], 'overallOfficials': [{'name': 'Hong Qi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hong Qi', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}