Clinical trial NCT03807869: Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Official title: Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: I-stent
glaucoma surgery
minimally invasive glaucoma surgery
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.

Detailed description: The scientific aim of the project is to estimate the average reduction of intraocular pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12 months observation period. The subject must suffer from glaucoma and cataract at the same time, and qualify for a cataract surgery. The group will be composed of 40 patients of the Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract removal surgery. They will be surgically implanted an I-stent by-pass during phacoemulsification.

Eligibility criteria: Inclusion Criteria:

* co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacity Classification System III)
* patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), with topical hypotensive treatment
* written consent to involvement and participation in the study for a period of at least 12 months was obtained from all patients after they had first been informed of the nature of the procedure and other surgical alternatives

Exclusion Criteria:

* no consent to participation in the study
* prior surgical and laser procedures in the area of the eye
* narrow- or closed-angle glaucoma
* post-inflammatory or post-traumatic secondary glaucoma
* chronic illness of the cornea or optic nerve
* advanced macular degeneration
* active inflammatory process
* pregnancy
* systemic steroid therapy

Primary outcomes:
measure: IntraOcular Pressure measurement (IOP)
timeFrame: baseline, 12 months
measure: Best Corrected Visual Acuity measurement (BCVA)
timeFrame: baseline, 12 months
Secondary outcomes:
measure: number of antiglaucoma medicines
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University
Study officials:
affiliation: Medical University of Bialystok
name: Zofia Mariak, Prof
role: STUDY_CHAIR
References:
citation: Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.
citation: Chansangpetch S, Lau K, Perez CI, Nguyen N, Porco TC, Lin SC. Efficacy of Cataract Surgery With Trabecular Microbypass Stent Implantation in Combined-Mechanism Angle Closure Glaucoma Patients. Am J Ophthalmol. 2018 Nov;195:191-198. doi: 10.1016/j.ajo.2018.08.003. Epub 2018 Aug 8.
citation: Kozera M, Konopinska J, Mariak Z, Rekas M. Effectiveness of iStent Trabecular Microbypass System Combined with Phacoemulsification versus Phacoemulsification Alone in Patients with Glaucoma and Cataract Depending on the Initial Intraocular Pressure. Ophthalmic Res. 2021;64(2):327-336. doi: 10.1159/000511456. Epub 2020 Sep 9.
citation: Konopinska J, Kozera M, Krasnicki P, Mariak Z, Rekas M. The Effectiveness of First-Generation iStent Microbypass Implantation Depends on Initial Intraocular Pressure: 24-Month Follow-Up-Prospective Clinical Trial. J Ophthalmol. 2020 Jun 23;2020:8164703. doi: 10.1155/2020/8164703. eCollection 2020.