[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07147647":3,"trial-entities:NCT07147647":133,"trial-summary:NCT07147647":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":38,"secondary_outcomes":42,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":80,"locations":83,"central_contacts":98,"overall_officials":102,"references":103,"see_also_links":129},"NCT07147647","25-SG27","Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Eye Pressure in Non-Caucasian Patients With Open Angle Glaucoma","Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Non-Caucasian Open Angle Glaucoma Patients","RECRUITING","2026-10","2025-08","2025-08-29","2025-07-16","Select Eye Care","INDUSTRY",false,"The goal of this clinical trial is to to evaluate how well Direct Selective Laser Trabeculoplasty (DSLT) lowers eye pressure in eyes of adult, non-Caucasian participants with primary open angle glaucoma. The main question it aims to answer is:\n\nWhat is the washed out eye pressure (eye pressure when not on any glaucoma medications) of participants 6 months after the Direct Selective Laser Trabeculoplasty (DSLT) procedure compared to the washed out eye pressure of participants prior to the DSLT procedure.\n\nParticipants will:\n\nUndergo the DSLT procedure in one or both eyes and visit the clinic 1 month, 3 months, and 6 months after the procedure to have their vision and eye pressure measured.","The goal of this clinical trial is to evaluate intraocular pressure (IOP) reduction of Direct Selective Laser Trabeculoplasty (DSLT) treatment in eyes of non-Caucasian patients with primary open angle glaucoma by assessing the washed out IOP reduction of DSLT at 6 months (compared to washed out baseline IOP), measuring the success rate of achieving ≥ to 20% IOP reduction from washed out baseline, assessing the proportion of medication-free eyes at 6 months post-DSLT, the need for secondary intervention (additional medications or procedures) at 6 months post-DSLT, and by comparing the washed out IOP reduction at 6 months post-DSLT compared to the washed out baseline IOP according to trabecular meshwork pigmentation grade.",[19],"Primary Open Angle Glaucoma (POAG)",[21,22,23,24,25],"Direct Selective Laser Trabeculoplasty","DSLT","Primary Open Angle Glaucoma","POAG","Glaucoma","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},60,"ESTIMATED",[34],{"type":35,"name":21,"description":36,"armGroupLabels":37},"DEVICE","DSLT using the Belkin Vision Eagle Device",[21],[39],{"measure":40,"timeFrame":41},"IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP.","6 Months post-DSLT",[43,46,50,52,54,58],{"measure":44,"timeFrame":45},"Proportion of eyes with ≥ 20% washed out IOP reduction at 6 months post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP.","6 months post-DSLT",{"measure":47,"description":48,"timeFrame":49},"Proportion of medication free eyes at 6 months post-DSLT","Eyes not using any glaucoma medications","6 Months Post-DSLT",{"measure":51,"timeFrame":49},"The number of participants who require secondary interventions (additional IOP-lowering procedures) prior to the completion of the 6 month post-DSLT visit.",{"measure":53,"timeFrame":49},"The number of participants who require secondary interventions (additional IOP-lowering medications) prior to the completion of the 6 month post-DSLT visit.",{"measure":55,"description":56,"timeFrame":57},"Change in 1 month and 3 month non-washed out IOP vs washed out baseline IOP","Measured in mmHg by Goldmann Applanation Tonometry","1 month and 3 months post-DSLT",{"measure":59,"description":60,"timeFrame":61},"Mean 6 month washed out IOP reduction compared with washed out baseline IOP stratified by Trabecular Meshwork pigmentation grade.","Trabecular meshwork pigment will be graded on a scale of 0-4 where 0 is no pigment and 4 is heavy pigmentation","6 Month Post-DSLT","ALL","18 Years",null,{"inclusion":66,"exclusion":71,"raw_text":79},[67,68,69,70],"Adult patients of Black African descent scheduled to undergo DSLT treatment in one or both eyes.","Diagnosis of mild to moderate primary open angle glaucoma (POAG).","Mild to moderate POAG will be defined as Stage 2 or better of the Hodapp-Anderson-Parrish glaucoma staging system.","Treatment naive or washed out IOP at time 0 ranging from ≥ 21 through 32 mm Hg.",[72,73,74,75,76,77,78],"Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0).","Previous glaucoma surgeries\u002Finterventions:","Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).","Secondary glaucoma:","Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.","Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.","Subjects who are pregnant, breast-feeding, or intend to become pregnant during the study period as determined by verbal inquiry.","Inclusion Criteria:\n\n* Adult patients of Black African descent scheduled to undergo DSLT treatment in one or both eyes.\n* Diagnosis of mild to moderate primary open angle glaucoma (POAG).\n* Mild to moderate POAG will be defined as Stage 2 or better of the Hodapp-Anderson-Parrish glaucoma staging system.\n* Treatment naive or washed out IOP at time 0 ranging from ≥ 21 through 32 mm Hg.\n\nExclusion Criteria:\n\n* Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0).\n* Previous glaucoma surgeries\u002Finterventions:\n* Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).\n* Secondary glaucoma:\n* Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.\n* Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.\n* Subjects who are pregnant, breast-feeding, or intend to become pregnant during the study period as determined by verbal inquiry.",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":13,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"Elkridge","Maryland","21075","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Research Coordinator","CONTACT","410-821-6400","hshea@vipeyes.com",{"lat":96,"lon":97},39.21261,-76.71358,[99],{"name":100,"role":92,"phone":93,"email":101},"Scott E LaBorwit, MD","scott.laborwit@vipeyes.com",[],[104,108,111,114,117,120,123,126],{"pmid":105,"type":106,"citation":107},"19834563","RESULT","Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174\u002F1874364100903020059.",{"pmid":109,"type":106,"citation":110},"16386972","Mills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30. doi: 10.1016\u002Fj.ajo.2005.07.044.",{"pmid":112,"type":106,"citation":113},"16148589","Hughes BA, Bacharach J, Craven ER, Kaback MB, Mallick S, Landry TA, Bergamini MV. A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%\u002Ftimolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. J Glaucoma. 2005 Oct;14(5):392-9. doi: 10.1097\u002F01.ijg.0000176935.08392.14.",{"pmid":115,"type":106,"citation":116},"12745004","Racette L, Wilson MR, Zangwill LM, Weinreb RN, Sample PA. Primary open-angle glaucoma in blacks: a review. Surv Ophthalmol. 2003 May-Jun;48(3):295-313. doi: 10.1016\u002Fs0039-6257(03)00028-6.",{"pmid":118,"type":106,"citation":119},"12049574","Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001\u002Farchopht.120.6.701.",{"pmid":121,"type":106,"citation":122},"36122660","Gazzard G, Konstantakopoulou E, Garway-Heath D, Adeleke M, Vickerstaff V, Ambler G, Hunter R, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology. 2023 Feb;130(2):139-151. doi: 10.1016\u002Fj.ophtha.2022.09.009. Epub 2022 Sep 17.",{"pmid":124,"type":106,"citation":125},"34433548","Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136\u002Fbjophthalmol-2021-319379. Epub 2021 Aug 25.",{"pmid":127,"type":106,"citation":128},"34003939","Goldenfeld M, Belkin M, Dobkin-Bekman M, Sacks Z, Blum Meirovitch S, Geffen N, Leshno A, Skaat A. Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. Transl Vis Sci Technol. 2021 Mar 1;10(3):5. doi: 10.1167\u002Ftvst.10.3.5.",[130],{"label":131,"url":132},"Change in Intraocular Pressure after Selective Laser Trabeculoplasty in North Indian Primary Open Angle Glaucoma Patients: A Prospective Analytical Study","https:\u002F\u002Fdoi.org\u002F10.7860\u002FJCDR\u002F2024\u002F74217.20250",{"nct_id":4,"conditions":134,"biomarkers":135},[23],[],{"nct_id":4,"found":137,"summary":138,"prompt_version":148},true,{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.","completed","DSLT for Reducing Eye Pressure in Non-Caucasian Patients With Open Angle Glaucoma","This study is looking at how well a procedure called Direct Selective Laser Trabeculoplasty (DSLT) using the Belkin Vision Eagle Device can lower eye pressure in adults with primary open angle glaucoma (POAG). POAG is an eye condition that can damage your optic nerve and cause vision loss. The study focuses on non-Caucasian patients of Black African descent with mild to moderate POAG. Researchers want to see if DSLT can reduce eye pressure significantly after 6 months, compared to before the procedure. They will also check how many patients no longer need glaucoma medications after 6 months. The study aims to enroll 60 participants, but its current status is unclear.","Participants will be followed for 6 months after the DSLT procedure.",110,"You would undergo the DSLT procedure in one or both eyes. You would then visit the clinic 1 month, 3 months, and 6 months after the procedure for vision and eye pressure measurements.","Not stated in the trial record.",[21],"v2"]