Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT07223866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-03', 'size': 912232, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-30T16:29', 'hasProtocol': True}, {'date': '2025-10-10', 'size': 177064, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-20T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study treatment \\& Methods:\n\n* Sequential cataract surgery with similar cataract grade 2-3+ based on LOCS III grading bilaterally; 2nd eye to be completed within 2-3 weeks of first eye\n* Randomize first eye to low vs high IOP, contralateral eye receives opposite IOP\n* Patient education on VAS with standard script\n* Standard pre-op drops: 2 drops of cyclopentolate 1%, tropicamide 1%, flurbiprofen sodium (Ocufen 0.03%), phenylephrine hydrochloride 2.5%, and 3 drops of marcaine 0.05%\n* After draping, patients receive OcuCoat on cornea and 3 drops of lidocaine, 1mg of Versed (midazolam for anxiety with no analgesic effects)\n* If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage recorded\n* Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional BP/HR values at the start of the case (room entry), 4 minutes'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-10-30', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rescue Medication', 'timeFrame': 'During cataract surgery', 'description': 'Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain'}], 'secondaryOutcomes': [{'measure': 'VAS Pain Score', 'timeFrame': 'During Phaco, I/A, and Visco Removal', 'description': 'Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain'}, {'measure': 'Surgeon Intraoperative Experience', 'timeFrame': 'During cataract surgery', 'description': '1- Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus \\& cortex removal)\n\n* 2- Good: \\>75% chamber stability and adequate efficiency\n* 3- Excellent: Minimal to no fluctuating chamber and excellent efficiency'}, {'measure': 'Cost Analysis', 'timeFrame': 'During cataract surgery', 'description': 'Cost-analysis on intraoperative medications utilized in high vs low IOP groups'}, {'measure': 'Breakthrough pain and discomfort High Axial Length', 'timeFrame': 'During cataract surgery', 'description': 'VAS Pain score on subjects with axial length of \\>24.5mm VAS score : 0 - no pain, 10 - unbearable pain If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage of surgery recorded.'}, {'measure': '1 day Post Op Patient Survey', 'timeFrame': '1 day post op cataract surgery, each eye', 'description': '* on experience (Iowa Satisfaction with Anesthesia Scale (ISAS)\n* on patient preference - What eye was more comfortable? (R/L)\n* surgical experience did you enjoy more? (R/L)\n* x% of eyes would undergo the same procedure again\n* x% of eyes would recommend the procedure to family and friends'}, {'measure': 'Anesthesiologist Review Blood Pressure', 'timeFrame': 'During cataract surgery', 'description': 'Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Blood Pressure values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.'}, {'measure': 'Anesthesiologist Review Pulse Rate', 'timeFrame': 'During cataract surgery', 'description': 'Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Pulse Rate values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract and IOL Surgery', 'Cataract Surgery Anesthesia', 'Cataract Surgery Experience', 'Nuclear Cataract']}, 'referencesModule': {'references': [{'pmid': '30528516', 'type': 'BACKGROUND', 'citation': 'Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6.'}, {'type': 'BACKGROUND', 'citation': 'Scarfone HA, Rodriquez EC. Evaluation of Early Changes of the Anterior Vitreous Interface after Cataract Surgery, using Low-Pressure Settings Determined by OCT. ASCRS 2023 May 6, San Diego Convention Center. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/88373'}, {'pmid': '34860481', 'type': 'BACKGROUND', 'citation': 'Donnenfeld ED, Mychajlyszyn D, Mychajlyszyn A, Stein R. Pain control and reduction of opioid use associated with intracameral phenylephrine1.0%-ketorolac 0.3% administered during cataract surgery. J Cataract Refract Surg. 2022 Jul 1;48(7):759-764. doi: 10.1097/j.jcrs.0000000000000855. Epub 2021 Oct 29.'}, {'pmid': '34737914', 'type': 'BACKGROUND', 'citation': 'Reddy AJ, Dang A, Dao AA, Arakji G, Cherian J, Brahmbhatt H. A Substantive Narrative Review on the Usage of Lidocaine in Cataract Surgery. Cureus. 2021 Oct 30;13(10):e19138. doi: 10.7759/cureus.19138. eCollection 2021 Oct.'}, {'pmid': '9917782', 'type': 'BACKGROUND', 'citation': 'Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6.'}, {'pmid': '9209989', 'type': 'BACKGROUND', 'citation': 'Gills JP, Cherchio M, Raanan MG. Unpreserved lidocaine to control discomfort during cataract surgery using topical anesthesia. J Cataract Refract Surg. 1997 May;23(4):545-50. doi: 10.1016/s0886-3350(97)80211-8.'}]}, 'descriptionModule': {'briefSummary': 'The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.', 'detailedDescription': 'Objective/ Unmet Medical Need:\n\nTo investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.\n\nDesign:\n\nProspective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.\n\nSTUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic.\n\nInclusion Criteria:\n\n* Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes\n* Unremarkable ocular health but inclusive of early AMD\n\nExclusion Criteria:\n\n* H/o ocular surgery including corneal refractive surgery\n* Compromised zonular integrity or stability\n* Uncontrolled diabetes and diabetic retinopathy\n* Small pupils\n* H/o systemic inflammatory disease/uveitis\n* H/o chronic pain medications (including narcotics) and benzodiazepine usage\n* Abnormal liver or renal function'}, 'identificationModule': {'nctId': 'NCT07223866', 'briefTitle': 'The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage', 'organization': {'class': 'OTHER', 'fullName': 'Wolfe Eye Clinic'}, 'officialTitle': 'The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage', 'orgStudyIdInfo': {'id': 'IIT #98621123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Centurion with Active Sentry at a traditionally high IOP setting', 'description': 'Centurion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.', 'interventionNames': ['Device: High IOP Setting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unity VCS/CS with Intelligent Fluidics at a low IOP setting', 'description': 'Unity VCS/CS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery.', 'interventionNames': ['Device: Low IOP Setting']}], 'interventions': [{'name': 'High IOP Setting', 'type': 'DEVICE', 'description': 'Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment', 'armGroupLabels': ['Centurion with Active Sentry at a traditionally high IOP setting']}, {'name': 'Low IOP Setting', 'type': 'DEVICE', 'description': 'Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment', 'armGroupLabels': ['Unity VCS/CS with Intelligent Fluidics at a low IOP setting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'contacts': [{'name': 'Robyn Kohler, RN', 'role': 'CONTACT', 'email': 'rkohler@wolfeclinic.com', 'phone': '515-223-8685'}], 'facility': 'Wolfe Eye Clinic and Wolfe Surgery Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}], 'centralContacts': [{'name': 'Robyn Kohler, RN', 'role': 'CONTACT', 'email': 'rkohler@wolfeclinic.com', 'phone': '515-223-8685'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Will provide with this submission.', 'ipdSharing': 'YES', 'description': 'We will share informed consent and study protocol.', 'accessCriteria': 'No patient specific data analysis will be shared. Will supply copies of IRB approved informed consent and protocol. Inquires to be sent to rkohler@wolfeclinic.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthew Rauen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew Rauen', 'investigatorAffiliation': 'Wolfe Eye Clinic'}}}}