Glaucoma Eye Clinical Trial
Official title:
XEN45 Gel Stent Implantation in Glaucoma Surgery
Verified date | May 2017 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Purpose: To report the follow-up data for patients who had XEN45 gel stent implantation, a
new method of minimally invasive glaucoma surgery (MIGS).
Material and Methods: Fifteen eyes of fifteen patients who had XEN45 gel stent implantation
surgery were investigated in the study. All the patients were examined preoperatively and at
the following postoperative time points: 1 day; 1 and 2 weeks; and 1, 2, 3, 6, and 12
months. Intraocular pressure (IOP) was measured by Goldmann applanation tonometry. Combined
surgical procedures (XEN 45 + phacoemulsification + intraocular lens) were performed in the
cases that had cataracts in addition to glaucoma.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2017 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma, with uncontrolled IOP and progressive visual field damage despite using the maximum tolerated dose of topical antiglaucomatous medications. Patients who had previous glaucoma surgery were included as well. Exclusion Criteria: - The exclusion criteria included primary closed-angle glaucoma, a history of uveitis, and the presence of corneal disease. Patients who did not attend follow-up visits were also excluded. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Trakya University |
Bussel II, Kaplowitz K, Schuman JS, Loewen NA; Trabectome Study Group.. Outcomes of ab interno trabeculectomy with the trabectome by degree of angle opening. Br J Ophthalmol. 2015 Jul;99(7):914-9. doi: 10.1136/bjophthalmol-2014-305577. Epub 2014 Oct 21. — View Citation
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Kerr NM, Wang J, Barton K. Minimally invasive glaucoma surgery as primary stand-alone surgery for glaucoma. Clin Exp Ophthalmol. 2016 Dec 8. doi: 10.1111/ceo.12888. [Epub ahead of print] Review. — View Citation
Landers J, Martin K, Sarkies N, Bourne R, Watson P. A twenty-year follow-up study of trabeculectomy: risk factors and outcomes. Ophthalmology. 2012 Apr;119(4):694-702. doi: 10.1016/j.ophtha.2011.09.043. Epub 2011 Dec 23. — View Citation
Lewis RA. Ab interno approach to the subconjunctival space using a collagen glaucoma stent. J Cataract Refract Surg. 2014 Aug;40(8):1301-6. doi: 10.1016/j.jcrs.2014.01.032. Epub 2014 Jun 15. Review. — View Citation
Minckler D, Mosaed S, Dustin L, Ms BF; Trabectome Study Group.. Trabectome (trabeculectomy-internal approach): additional experience and extended follow-up. Trans Am Ophthalmol Soc. 2008;106:149-59; discussion 159-60. — View Citation
Nouri-Mahdavi K, Brigatti L, Weitzman M, Caprioli J. Outcomes of trabeculectomy for primary open-angle glaucoma. Ophthalmology. 1995 Dec;102(12):1760-9. Review. — View Citation
Pérez-Torregrosa VT, Olate-Pérez Á, Cerdà-Ibáñez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A, Duch-Samper A. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol. 2016 Sep;91(9):415-21 — View Citation
Pinto Ferreira N, Abegão Pinto L, Marques-Neves C. XEN Gel Stent Internal Ostium Occlusion: Ab-Interno Revision. J Glaucoma. 2017 Apr;26(4):e150-e152. doi: 10.1097/IJG.0000000000000625. — View Citation
Richter GM, Coleman AL. Minimally invasive glaucoma surgery: current status and future prospects. Clin Ophthalmol. 2016 Jan 28;10:189-206. doi: 10.2147/OPTH.S80490. eCollection 2016. Review. — View Citation
Sheybani A, Lenzhofer M, Hohensinn M, Reitsamer H, Ahmed II. Phacoemulsification combined with a new ab interno gel stent to treat open-angle glaucoma: Pilot study. J Cataract Refract Surg. 2015 Sep;41(9):1905-9. doi: 10.1016/j.jcrs.2015.01.019. Epub 2015 Oct 23. — View Citation
Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 20 — View Citation
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Vera V, Horvath C. Xen Gel Stent: The solution designed by AqueSys. In: Samples, JR, Ahmed, IIK, editors. Surgical innovations in glaucoma. New York: Springer Science+Business Media; 2014, p. 189-198.
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular pressure | Mean intraocular pressure values | Postoperative 12 months | |
Secondary | Antiglaucomatous medications | Mean number of antiglaucomatous medications | Postoperative 12 months | |
Secondary | Incidence of complications | Complications due to surgery | Postoperative 12 months |
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