Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 8:15 PM
Study NCT ID:
NCT05001932
Status:
UNKNOWN
Last Update Posted:
2021-11-01
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D015858', 'term': 'Anisometropia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '120 days', 'description': 'Investigate if MIOLs, mono-vision and mini-vision provides better visual function, quality of vision and spectacle free vision compared to monofocal IOLs. This will be evaluated by questionnaires and objective measurements as described.'}], 'secondaryOutcomes': [{'measure': 'Tolerance of anisometropia', 'timeFrame': '120 days', 'description': 'Investigate if the tolerance of anisometropia is better in the elderly population compared to a younger population (SMILE patients). This will be evaluated by questionnaires and objective measurements as described.'}, {'measure': 'Aniseikonia tolerance range (ATR)', 'timeFrame': '120 days', 'description': 'Compare ATR in all four arms and in a SMILE population to investigate if ATR is a future screening tool that can predict which patients cannot tolerate anisometropia'}, {'measure': 'Aniseikonia tolerance range (ATR)', 'timeFrame': '120 days', 'description': 'Investigate if ATR is reproducible and clinical useful in cataract patients with poor vision'}, {'measure': 'Anisometropia', 'timeFrame': '120 days', 'description': 'Investigate if anisometropia \\> 3 diopters are better tolerated than previously described. This will be evaluated by questionnaires and objective measurements as described.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract', 'Anisometropia', 'Aniseikonia Tolerance Range'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Cataract surgery is the most common eye surgery in the world. If the patient with cataract uses spectacles and both patient and surgeon find it beneficial, it is possible to compensate for the spectacles during surgery and thereby obtain a spectacle-free distance vision or spectacle-free near vision. Becoming spectacle free increases quality of life substantially and is one of the primary wishes in cataract patients. Socioeconomically, spectacle free life is beneficial as it reduces fall tendency in the elderly population. Multifocal lenses warrant the possibility of obtaining a spectacle free vision at near, intermediate and distance. It is also possible to obtain spectacle free distance and near vision or distance and intermediate vision by using traditional artificial monofocal lenses but making one eye spectacle free for distance and the other eye spectacle free for near or intermediate vision. Currently, it is not know which procedure is most beneficial for cataract patients.\n\nIn a recent PhD, the investigators developed a method, Aniseikonia Tolerance Range (ATR), that can assess how much refractive change a patient can endure without impairing stereopsis. The results demonstrated large variation in the tolerance of image difference. This method can be a future tool to assess whether a patient can tolerate the refraction that is considered most beneficial to the patient. The knowledge is important as it can help avoid improper lens choice in cataract surgery and thereby avoid stereopsis problems.', 'detailedDescription': 'Background This randomized clinical trial aims to improve visual outcomes in cataract surgery by examining which intraocular lenses (IOL)/operation methods that provide highest patient satisfaction, visual function and spectacle free vision. Furthermore, the tolerance of surgical induced refractive difference (anisometropia) will be examined and a screening method to assess how much anisometropia a patient can endure will be validated. The investigators will examine if the tolerance of anisometropia \\> 3 diopters is better than previously described and examine if ATR can predict which patients will experience binocular problems if exposed to surgical induced aniseikonia.These results will lead to higher patient satisfaction, better visual outcomes with elimination of patients with mediocre refractive results and visual problems due to anisometropia.\n\nIn addition the investigators will examine whether ATR is reproducible by examining the variation in the multiple measurements and in a prospective study the investigators will investigate the inter and intra person reproducibility of ATR.\n\n100 refractive patients with healthy eyes except myopia \\> 3 diopters and \\< 6 diopters, who will have a Small Incision Lenticule Extraction (SMILE) surgery will have all investigations done. The patients will have a bilateral SMILE with a interval of seven weeks and will in between the two procedures have a surgically introduced anisometropia that will provide further knowledge on anisometropia and ATR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral cataract\n* Axial length: 20-27 mm\n* ACD \\> 2.3 mm\n* Pupil size: ≥ 5.0 mm in dilatation\n* Pupil siza: ≥ 2.5 mm in photo topic condition\n* Stereoacuity ≤ 480 seconds of arch\n\nExclusion Criteria:\n\n* Former intraocular surgery\n* Other eye disease (amblyopia, strabismus, corneal pathology, glaucoma, uveitis, age related maculopathy\n* Other retinal diseases\n* Risk of weak zonules due to PEX or former trauma\n* Astigmatism ≥ 1.0 diopter\n* Diabetes\n* Axial length difference between the two eyes \\> 0.3 mm\n* Dementia\n* Lack of cooperation kooperation\n* Stereoacuity \\> 480 seconds of arc\n* Complicated cataract surgery or postoperative complications (intraocular infection, retinal detachment, macular edema\n* Business driving\n* Night driving'}, 'identificationModule': {'nctId': 'NCT05001932', 'acronym': 'ORAPSCA', 'briefTitle': 'Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery', 'orgStudyIdInfo': {'id': 'H 18058722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multifocal', 'description': 'Patients will receive a multifocal lens bilateral (Alcon Vivity).', 'interventionNames': ['Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mono-vision', 'description': 'Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant myopia of -2.50D.', 'interventionNames': ['Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minimono-vision', 'description': 'Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant -1.25D.', 'interventionNames': ['Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monofocal', 'description': 'Patients will receive a monofocal lens bilateral. Target refraction will be -0.25D.', 'interventionNames': ['Procedure: Cataract surgery']}], 'interventions': [{'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'Randomized Clinical Trial', 'armGroupLabels': ['Minimono-vision', 'Mono-vision', 'Monofocal', 'Multifocal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne Guldhammer Skov, MD', 'role': 'CONTACT', 'email': 'anne.guldhammer.skov.01@regionh.dk', 'phone': '+4538634707'}], 'facility': 'Rigshospitalet - Glostrup', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Anne Guldhammer Skov, MD', 'role': 'CONTACT', 'email': 'anne.guldhammer.skov.01@regionh.dk', 'phone': '+45 38 63 38 63'}], 'overallOfficials': [{'name': 'Morten la Cour, MD, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Glostrup'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Anne Guldhammer Skov, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}