Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT00461435
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-17', 'studyFirstSubmitDate': '2007-04-17', 'studyFirstSubmitQcDate': '2007-04-17', 'lastUpdatePostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Retinitis Pigmentosa']}, 'descriptionModule': {'briefSummary': 'Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual function in retinitis pigmentosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clearly hereditary RP (we performed to all of them genetic analysis for rhodopsin, and peripherin genes, only 4 patient with ADRP showed point mutation 3 on codon 135 and 1 on codon 347); best corrected visual acuity (BCVA) ≥ 0.50 logMAR; visual field ≥ 3 degree diameter circle; recordable ERG.\n\nExclusion Criteria:\n\n* Exclusion criteria were: patients with sporadic RP; BCVA ≤ 0.50 logMAR; visual field ≤ 3 degree diameter circle; not recordable ERG.'}, 'identificationModule': {'nctId': 'NCT00461435', 'briefTitle': 'Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Policlinico Umberto I'}, 'officialTitle': 'Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa', 'orgStudyIdInfo': {'id': 'SS01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hyperbaric oxygen therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Azienda Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Enzo Maria Vingolo, PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Umberto I, Dipartimento di Oftalmologia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Policlinico Umberto I', 'class': 'OTHER'}}}}