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

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

combined glaucoma surgery

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring I-stent, glaucoma surgery, minimally invasive glaucoma surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

coexisting glaucoma and cataract

Arm Description

Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery

Outcomes

Primary Outcome Measures

IntraOcular Pressure measurement (IOP)

change in the level of intraocular pressure measured with Goldmann applanation tonometer

Best Corrected Visual Acuity measurement (BCVA)

change in best corrected visual acuity measured with Snellen charts

Secondary Outcome Measures

number of antiglaucoma medicines

change in number of antiglaucoma medicines used before and after surgery

Full Information

NCT ID

NCT03807869

First Posted

January 15, 2019

Last Updated

February 11, 2020

Sponsor

Medical University of Bialystok

1. Study Identification

Unique Protocol Identification Number

NCT03807869

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Bialystok

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

I-stent, glaucoma surgery, minimally invasive glaucoma surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

coexisting glaucoma and cataract

Arm Type

Experimental

Arm Description

Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery

Intervention Type

Procedure

Intervention Name(s)

combined glaucoma surgery

Intervention Description

phacoemulsification of cataract and I-stent by-pass implantation

Primary Outcome Measure Information:

Title

IntraOcular Pressure measurement (IOP)

Description

change in the level of intraocular pressure measured with Goldmann applanation tonometer

Time Frame

baseline, 12 months

Title

Best Corrected Visual Acuity measurement (BCVA)

Description

change in best corrected visual acuity measured with Snellen charts

Time Frame

baseline, 12 months

Secondary Outcome Measure Information:

Title

number of antiglaucoma medicines

Description

change in number of antiglaucoma medicines used before and after surgery

Time Frame

baseline, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zofia Mariak, Prof

Organizational Affiliation

Medical University of Bialystok

Official's Role

Study Chair

Facility Information:

Facility Name

Medical University

City

Białystok

ZIP/Postal Code

15-089

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement

Citations:

PubMed Identifier

29476443

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.

Results Reference

background

PubMed Identifier

30098352

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.

Results Reference

result

PubMed Identifier

32906138

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.

Results Reference

derived

PubMed Identifier

32676205

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.

Results Reference

derived

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

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