Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02526706
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a Type of Blue Dye to Observe Bleb Function During Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014343', 'term': 'Trypan Blue'}], 'ancestors': [{'id': 'D001391', 'term': 'Azo Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009282', 'term': 'Naphthalenesulfonates'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-19', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intraocular pressure (IOP) post surgery', 'timeFrame': '6 months', 'description': 'IOP is measured pre and post operation and in all the follow up visits.'}, {'measure': 'The Indiana Bleb Appearance Grading System (IBAGS) will be used for bleb grading', 'timeFrame': '6 months', 'description': 'Evaluation based on pre-operative bleb photography will be compared to intraoperative VisionBlue bleb scoring by using Indiana Bleb Appearance Grading System (IBAGS) as a standard structured framework for comparison. The IBAGS method uses bleb photography to create a score based on bleb height (0 to 3), extent (0 to 3), vascularity (0 to 4), and Seidel test leakage (0 to 2).'}, {'measure': 'Change in Glaucoma medication from pre to post surgery', 'timeFrame': '6 months', 'description': 'Observe the changes in glaucoma medication after surgery procedure and at all follow up visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bleb filtration', 'VisionBlue'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The investigators aim to conduct a prospective clinical pilot study to investigate the use of VisionBlue staining administered during cataract surgery to 20 patients with history of trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb. The investigators also aim to develop a standard classification system for assessing filtering bleb function during cataract surgery.', 'detailedDescription': 'Twenty (20) patients with history of trabeculectomy who have been scheduled for cataract extraction with posterior chamber intraocular lens implant, will be recruited from Wills Eye Hospital Glaucoma Service.\n\nSubjects will undergo a comprehensive ophthalmic evaluation prior to scheduling cataract surgery. The following data will be recorded: Demographic information including age, race, and gender, Best corrected visual acuity, IOP measured by Goldmann applanation tonometry, Bleb morphology evaluation using the Indiana Bleb Appearance Grading Scale (IBAGS), Filtering bleb photographs and anterior segment OCT of the bleb will be taken at the baseline examination.\n\nThe patient will be taken to the operating room and will be prepped.Non-preserved Lidocaine (1%) will be injected into the anterior chamber for anesthesia, followed by injection of one complete vial of VisionBlue (0.5 mL). An injection of BSS will be administered through the paracentesis port until the IOP is approximately 20mHg (estimated by the surgeon by palpation), with a waiting period of 20 seconds. Another injection of BSS will then be administered to wash out the VisionBlue. A set of microscopic photographs will be taken through the intraoperative microscope following washout of VisionBlue, with bleb grading performed by the physician: 1+ to 4+ stain (based on standard set of photos).\n\nCataract extraction will then take place following typical phacoemulsification procedure. At the end of the case, after insertion of the intraocular lens implant into the capsular bag and removal of viscoelastic material from the eye, an additional set of microscope photographs will be taken and graded on same scale.\n\nThe time (in minutes) between the initial and the final bleb grading will be measured and recorded. Intraoperative complications will be recorded as well.\n\nFollow-up of subjects will take place post-operatively at 1 day, 1 week, 1 month, 3 month, and 6 month follow-up visits. Color photos of bleb will be performed post-operatively at 1 day, 1 month, and 6 months. At each visit, we will also record the number of glaucoma medications, post-operative complications and need for re-operations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glaucoma patients with history of previous trabeculectomy surgery who are scheduled for cataract surgery.\n* Glaucoma defined as (both requirements must be met): 1) Characteristic glaucomatous disc damage as demonstrated by local narrowing, notching, or absence of the neuroretinal rim in the absence of disc pallor elsewhere. 2) Characteristic glaucomatous visual field (VF) deficits.\n* Over 21 years of age\n\nExclusion Criteria:\n\n* Intraocular surgery or laser procedure within 3 months prior to the planned cataract surgery.\n* Active ocular infection or inflammation.\n* History of glaucoma drainage device (tube-shunt) implantation.\n* Allergy to VisionBlue or history of allergy to other ophthalmic dyes'}, 'identificationModule': {'nctId': 'NCT02526706', 'briefTitle': 'Using a Type of Blue Dye to Observe Bleb Function During Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'VisionBlue for the Assessment of Filtering Bleb Functioning During Cataract Surgery', 'orgStudyIdInfo': {'id': '15-494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glaucoma Study Group', 'description': 'Glaucoma patients scheduled for trabeculectomy were recruited for this study and VisionBlue dye is injected prior to the surgery.', 'interventionNames': ['Other: VisionBlue']}], 'interventions': [{'name': 'VisionBlue', 'type': 'OTHER', 'description': 'VisionBlue is a staining solution designed to assist in making complete capsulorhexis during cataract surgery. The dye is injected into the anterior chamber via a paracentesis port and stains the anterior lens capsule, assisting in adequate visualization of the anterior lens capsule. This study proposes to explore the use of VisionBlue during cataract surgery as a means to assess functioning of an existing filtering bleb placed during prior trabeculectomy in patients with glaucoma.', 'armGroupLabels': ['Glaucoma Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital, Glaucoma Service', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Marlene Moster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Marlene Moster, MD', 'investigatorAffiliation': 'Wills Eye'}}}}