Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma

Glaucoma Clinical Trial

Official title:

Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807869
• Other study ID #: 1772
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Procedure:
• combined glaucoma surgery
phacoemulsification of cataract and I-stent by-pass implantation

Locations

Country	Name	City	State
Poland	Medical University	Bialystok

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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 — View Citation

Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Jünemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(®) Trabecular Stents, One iStent Supra(®) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IntraOcular Pressure measurement (IOP)	change in the level of intraocular pressure measured with Goldmann applanation tonometer	baseline, 12 months
Primary	Best Corrected Visual Acuity measurement (BCVA)	change in best corrected visual acuity measured with Snellen charts	baseline, 12 months
Secondary	number of antiglaucoma medicines	change in number of antiglaucoma medicines used before and after surgery	baseline, 12 months