[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hôpital Privé de la Baie\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100633785","efficacy-and-safety-of-a-releasable-intraluminal-suture-technique-to-reduce-hypotony-following-glaucoma-surgery-using-the-preserflo-device-100633785",false,"NCT07531199","Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Glaucoma Surgery Using the Preserflo Device","PFLO","Inclusion Criteria:\n\n* Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with an indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and an open iridocorneal angle (trabeculum visible on gonioscopy, Shaffer classification grade 3-4)\n\n  * Healthy, mobile conjunctiva (without scarring or adhesions).\n  * The indication for glaucoma surgery is defined as uncontrolled IOP or worsening of visual fields despite maximum tolerated medical therapy, and with either a previous failure of trabeculectomy or a risk of failure.\n  * Maximum tolerated medical therapy: 3 or more classes of ocular hypotensive treatment, or fewer if there is an allergy or intolerance to the treatment. Visual field defects must be more severe than -3 dB in mean deviation.\n\nExclusion Criteria:\n\n* severe systemic pathologies\n* other ophtalmic pathologies (except cataract)\n* previous intraocular surgery (except cataract)\n* neovascular glaucoma or iris neovascularization\n* pachymetry \\\u003C 490µm or \\> 620µm\n* contraindication to PRESERFLO Microshunt","ALL","18 Years",{"count":19,"type":20},192,"ESTIMATED","INTERVENTIONAL",[23],"NA","Glaucoma is a common and irreversible disease of the optic nerve. It is the second leading cause of blindness worldwide. Glaucoma can be treated with medication, laser therapy, or surgery; the latter is often necessary. Traditional surgeries are invasive and carry a high rate of complications (hypotony, endophthalmitis, cataracts, etc.). Consequently, several types of micro-invasive surgeries (MIGS) and less invasive but effective surgeries, LIGS, have been developed to reduce surgical risks while maintaining effectiveness in lowering intraocular pressure (IOP). PRESERFLO is a drainage system less than 1 mm thick that regulates the outflow of aqueous humor from the eye. It is made of a soft, flexible biomaterial that conforms to the curvature of the eye. This biomaterial does not trigger a negative immune response. PRESERFLO is an example of a recently developed, powerful LIGS procedure (with preliminary results demonstrating efficacy and safety). PRESERFLO is already in use in France (marketing authorization and CE marking obtained) and is covered by social security.\n\nThis technique is highly effective in lowering IOP, but it may be associated with hypotony, although less frequently than with trabeculectomy. The use of a releasable suture placed inside the Preserflo to limit drainage and, consequently, reduce the risk of hypotony has been described with good results in preliminary studies. Nevertheless, it is necessary to evaluate the efficacy and safety of this technical modification in a randomized, prospective clinical trial to better understand whether this modification is beneficial for improving the treatment of patients with glaucoma.",[26],"Glaucoma","RECRUITING","2026-09-29",{"date":30,"type":31},"2026-10-02","ACTUAL",{"date":33,"type":31},"2026-09-17",{"date":35,"type":20},"2029-02-28",{"name":37,"class":38},"Hôpital Privé de la Baie","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":5},"100591386","efficacy-and-safety-of-tran-cannula-in-combined-pseudoexfoliative-glaucoma-and-cataract-surgery-compared-with-augmented-ocular-irrigation-100591386","NCT06979752","Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation","Inclusion Criteria:\n\n* Patients with cataract and early-to-moderate pseudoexfoliative glaucoma (GPX) scheduled for isolated cataract surgery.\n* Reliable visual field, Humphrey 24-2, Sita-Fast, with typical glaucoma alterations, and with mean deviation ≤-12 dB.\n* OCT with ganglion cell alterations and fibers typical of glaucoma.\n* Typical glaucomatous neuropathy\n* Slit-lamp signs of pseudoexfoliation.\n* Open angle (2 to 4, according to Shaffer classification) determined by gonioscopy.\n* Untreated eye pressure \\>21 mmHg and \\\u003C33 mmHg\n\nExclusion Criteria:\n\n* Presence of other ophthalmological pathologies (except cataract or mild dry eye)\n* History of intraocular surgery in the last 12 months, history of trauma\n* History of laser trabeculoplasty (TLA or SLT) in the previous 12 months\n* Visual acuity below \"finger count\n* Myopia ≥ 6 dioptres, hyperopia ≥ 5 dioptres\n* Iridocorneal angle closure (and angle-closure glaucoma), any other type of non-pseudoexfoliative glaucoma, iris neovascularization\n* Pachymetry \\\u003C 490 μm or \\> 620 μm; or corneal pathology or other condition that makes accurate IOP measurements with flattening tonometry, ultrasonic pachymetry or specular microscopy impossible.\n* Presence of severe systemic pathologies",{"count":47,"type":20},58,[23],"Pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. Tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork.\n\nThe main objective of this study is to evaluate the efficacy of the Tran cannula, in comparison with increased irrigation, in lowering intraocular pressure (IOP) in patients with pseudoexfoliative glaucoma and treated for glaucoma, and with an indication for isolated cataract surgery.",[51,52],"Glaucoma, Open Angle, Pseudo-exfoliative","Cataract",{"date":54,"type":31},"2026-09-30",{"date":56,"type":31},"2025-06-04",{"date":58,"type":20},"2029-02-02",{"name":37,"class":38},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100574506","efficacy-and-safety-of-the-elios-laser-in-combined-cataract-and-glaucoma-surgery-100574506","NCT06760169","Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery","ELIOS","Inclusion Criteria:\n\n* Patients ≥ 18 years of age who agree to take part in the study and have signed an informed consent form\n* Visually significant cataract with indication for surgery\n* Primary open-angle glaucoma, or secondary open-angle glaucoma (pseudoexfoliative glaucoma or pigmentary glaucoma) with indication for cataract surgery.\n* Open iridocorneal angle (Shaffer classification grade 2-4)\n* Early to moderate glaucoma (advanced glaucoma, with MD from VFs worse than -12dB, will be excluded)\n\nExclusion Criteria:\n\n* Presence of severe systemic pathologies 2024-A01891-46\\_Protocol\\_V6\\_21112024\\_Elios Page 20 \u002F 58\n* Pregnant or breastfeeding women\n* \\\u003C18 years of age\n* Presence of other ophthalmological pathologies (except cataracts), and exclusion of severe dry eye.\n* History of intraocular surgery, trauma, or conjunctival scarring in the quadrant intended for surgery\n* Visual acuity worse than \"counting fingers\".\n* Closure of the iridocorneal angle (and angle-closure glaucoma), angle-closure glaucoma secondary to iridocorneal synechiae, neovascular glaucoma or neovascularization of the iris.\n* Normal-pressure glaucoma\n* Pachymetry \\\u003C 490 um or \\> 620 μm\n* Glaucomatous visual field with mean deviation worse than ≤-12 dB\n* IOP \\> 35 mmHg\n* Autoimmune disorder, especially collagenosis\n* Patient under protective supervision\n* Patient not covered by a social security scheme","80 Years",{"count":69,"type":20},46,[23],"Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). As a result, several types of micro-invasive surgery (MIGS) have been developed to reduce the risks of surgery while maintaining their effectiveness in lowering intraocular pressure (IOP). The ELIOS laser system is the only ophthalmological excimer laser designed for the surgical treatment of glaucoma. The aim of the procedure is to ablate the trabecular meshwork and inner wall of Schlemm´s canal ab interno, with the creation of 10 microchannels of 210 um in the trabeculum using the ELIOS laser with a wavelength of 308 nm, in order to improve trabecular outflow to achieve a reduction in IOP. The ELIOS laser is an example of Microinvasive Glaucoma surgery (MIGS) with published results demonstrating efficacy and safety. The ELIOS laser is already in use in France (AMM \u002F CE mark achieved). Its use as part of a prospective interventional study will enable us to collect data in order to treat patients more effectively and improve the quality of care provided to glaucoma patients.",[26],[74,75,76,77],"glaucoma","ELIOS laser","micro-invasive surgery","goniotomy",{"date":54,"type":31},{"date":80,"type":31},"2025-01-05",{"date":82,"type":20},"2028-02-28",{"name":37,"class":38},""]