Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-11 @ 11:41 PM
Study NCT ID:
NCT06808633
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Glaucoma Quality of Life-15 Questionnaire at 12 months after DSLT.', 'timeFrame': '12 months', 'description': 'Glaucoma Quality of Life-15 Questionnaire at 12 months after DSLT. It consists of 15 questions asking about patients difficulty for performing everyday tasks, which the patient must grade from 1 to 5, with 1 being that patient has no difficulty performing the task and 5 that he has severe diificulties. Values range from 15 (no difficulties for any activity) to 45 (has severe difficulties for performing all activities)'}], 'primaryOutcomes': [{'measure': 'Percentage change in IOP six months after DSLT compared to baseline.', 'timeFrame': '6 months after DLST application', 'description': 'Percentage change in IOP six months after DSLT compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline.', 'timeFrame': '12 months', 'description': 'Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline.'}, {'measure': 'Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline.', 'timeFrame': '12 months', 'description': 'Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline.'}, {'measure': 'Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months.', 'timeFrame': '12 months', 'description': 'Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months.'}, {'measure': 'Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months', 'timeFrame': '12 months', 'description': 'Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months'}, {'measure': 'Mean number of medications 3, 6 and 12 months after DSLT (accounting for those on no medications as well when calculating the average).', 'timeFrame': '12 months', 'description': 'Mean number of medications 3, 6 and 12 months after DSLT (accounting for those on no medications as well when calculating the average).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'direct selective laser trabeculoplasty'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Prospective, single-arm, single-center, non-randomized, non-comparative study including naïve patients attending our center diagnosed with glaucoma, who have been recommended treatment with direct selective laser trabeculoplasty (DSLT) by their ophthalmologist and who are under no hypotensive medication. DSLT treatment will be performed with the Voyager DSLT system; it will consist of the application of 120 laser pulses of preset 3 ns and a preset 400 μm spot size, with an energy of 1.8 mJ delivered to the limbus through a full 360 degrees.\n\nThe study will evaluate the effect of DSLT on intraocular pressure (IOP). Baseline IOP will be the IOP measured with Goldman applanation tonometry by the investigator on the day of treatment, prior to the application of DSLT. Patients will be seen one week (±2 days), one month (±7 days), three months (±15 days), six months (±30 days) and 12 months (±40 days) after DSLT treatment. In each of these visits, the attending ophthalmologist will measure IOP with Goldmann applanation tonometry and record the presence of any relevant ocular signs and query patients regarding potential adverse events. The study´s main end-point will be percentage reduction in IOP six months after DSLT compared to baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with open angle glaucoma in study eye and scheduled for both eyes being treated after bilateral laser indication.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: • Age over 18 years\n\n• Diagnosis of open angle glaucoma in eye study and scheduled for both eyes being treated after bilateral laser indication. The diagnosis of glaucoma will be based on the presence of optic nerve damage that is compatible with glaucoma in the absence of any other cause that could have produced this damage, with an IOP value\\>21 mmHg.\n\nExclusion Criteria:\n\n* Patients diagnosed with uveitis, angle closure or congenital glaucoma.\n* Presence of anterior peripheral synechiae\n* Patients unable to complete three, six- and 12-months follow-up.\n* Patients having undergone intraocular surgery, save for uneventful phacoemulsification (performed at least 6 months prior to inclusion)'}, 'identificationModule': {'nctId': 'NCT06808633', 'briefTitle': 'Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Clínica Rementería'}, 'officialTitle': 'Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma', 'orgStudyIdInfo': {'id': '25/033-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study participants', 'description': 'Age over 18 years Diagnosis of open angle glaucoma instudy eye and scheduled for both eyes being treated after bilateral laser indication. The diagnosis of glaucoma will be based on the presence of optic nerve damage that is compatible with glaucoma in the absence of any other cause that could have produced this damage, with an IOP value\\>21 mmHg.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28010', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Inés Contreras', 'role': 'CONTACT', 'email': 'contreras@clinicarementeria.es', 'phone': '+34913083838'}], 'facility': 'Clínica Rementería', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Inés Contreras', 'role': 'CONTACT', 'email': 'contreras@clinicarementeria.es', 'phone': '+34913083838'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'At the end of study (expected winter 2026) and for five years', 'ipdSharing': 'YES', 'description': 'Age, gender, baseline IOP, severity of glaucoma, IOP at each follow-up visit, need for glaucoma medications', 'accessCriteria': 'Data deposited in a dataset repository, accessed by identified researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clínica Rementería', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}