Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT03603067
Status:
UNKNOWN
Last Update Posted:
2018-07-27
First Post:
2018-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562573', 'term': 'cyclopia sequence'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2018-07-07', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual function', 'timeFrame': 'One day before surgery and one day, one months, three months and six months after surgery.', 'description': 'BCVA and intraocular pressure (IOP) wlll be recorded.'}], 'primaryOutcomes': [{'measure': 'Level of anxiety', 'timeFrame': 'Change from Baseline HAMA score at 6 months.', 'description': 'Hamilton anxiety scale（HAMA）will be filled in by each patient and the final score will be recorded. The total score ranges from 0-56. A score less than 7 means no symptom of anxiety. A score between 7 to 14 means possible anxiety. A score between 14-21 means mild anxiety. A score between 21-29 means moderate anxiety. A score more than 29 means severe symptom of anxiety.'}, {'measure': 'Level of depression', 'timeFrame': 'Change from Baseline HAMD score at 6 months.', 'description': 'Hamilton depression scale (HAMD) will be filled in by each patient and the final score will be recorded. The total score ranges from 0-56. A score less than 8 means no symptom of depression. A score between 8 to 35 means mild or moderate depression. A score more than 35 means severe symptom of depression.'}], 'secondaryOutcomes': [{'measure': 'Level of social support', 'timeFrame': 'Change from Baseline SSRS score at 6 months.', 'description': 'Social support rating scale (SSRS) will be filled in by each patient and the final score will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['monophthalmos', 'social psychology', 'ocular surgery'], 'conditions': ['Psychology, Social', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '19929654', 'type': 'BACKGROUND', 'citation': 'Hirneiss C, Neubauer AS, Herold TR, Kampik A, Hintschich C. Utility values in patients with acquired anophthalmus. Orbit. 2009;28(6):332-6. doi: 10.3109/01676830903104702.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision.', 'detailedDescription': 'Monophthalmos means the best corrected visual acuity (BCVA) of the worse eye is less than 0.05 or the central visual field (CFOV) is less than 5°. The ocular surgery of the better eye in monophthalmic patients is of high risk. On the one hand the surgical failure will result in the patient falling into permanent darkness. On the other hand the monophthalmic patient may have the same disease in both two eyes such as high axial myopia, uveitis and glaucoma, which will increase the surgical risk. There is still no consensus on whether it is necessary to take risks to perform this kind of operation. In this study we will evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision. The necessity of the ocular surgery in monophthalmic patients will be evaluated from the point of social psychology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in Shanghai Aier Eye Hospital and are intended to receive ocular surgery in one of two eyes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intention to receive ocular surgery in one of two eyes.\n* Free from prior mental disorders.\n* Without general disease and can tolerate the operation.\n* Communication without difficulty.\n\nExclusion Criteria:\n\n* With prior mental disorders.\n* Can not tolerate the operation.\n* Communication with difficulty.'}, 'identificationModule': {'nctId': 'NCT03603067', 'briefTitle': 'The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aier School of Ophthalmology, Central South University'}, 'officialTitle': 'A Prospective, Non-randomized, Controlled Study: To Evaluate the Psychological Status of Monophthalmic Patients Before and After Ocular Surgery', 'orgStudyIdInfo': {'id': 'SHIRB2018018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'monophthalmic group', 'description': 'The BCVA of the worse eye is less than 0.05 or CFOV is less than 5°. The better eye need to receive ocular surgery.', 'interventionNames': ['Procedure: Ocular surgery']}, {'label': 'Normal group', 'description': 'The BCVA of the worse eye is more than 0.3 and CFOV is more than 10°. One of two eyes need to receive ocular surgery.', 'interventionNames': ['Procedure: Ocular surgery']}], 'interventions': [{'name': 'Ocular surgery', 'type': 'PROCEDURE', 'description': 'Different ocular surgeries (including vitreoretinal surgery, cataract surgery, anti-glaucoma surgery etc) will be performed in one eye of the patient. In monophthalmic patient group the surgery will be performed in eye with better visual acuity.', 'armGroupLabels': ['Normal group', 'monophthalmic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuyun Qian', 'role': 'CONTACT', 'email': 'qianzhuyun552@126.com', 'phone': '+8613817109809'}, {'name': 'Wensheng Li', 'role': 'CONTACT', 'email': 'drlws@qq.com', 'phone': '+8618650424985'}], 'facility': 'Shanghai Aier Eye Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhuyun A Qian', 'role': 'CONTACT', 'email': 'qianzhuyun552@126.com', 'phone': '+8613817109809', 'phoneExt': '+8613817109809'}, {'name': 'Wensheng A Li', 'role': 'CONTACT', 'email': 'drlws@qq.com', 'phone': '+8618650424985', 'phoneExt': '+8618650424985'}], 'overallOfficials': [{'name': 'Wensheng Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Aier Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will be partly shared in published papers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aier School of Ophthalmology, Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}