Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

NCT ID: NCT02873806

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-11-08

Brief Summary

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Detailed Description

The study design is as follows:

• Prospective, single-arm study.
• Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg.
• Subjects on two topical ocular hypotensive medications (one a prostaglandin).
• Implantation of two iStent inject devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued).
• IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP.
• Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout).
• Descriptive statistics will be tabulated.
• Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.

Conditions

Open-angle Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 micro-bypass stents & travoprost

Two iStent inject micro-bypass stents and topical travoprost

Intervention:

• Implantation of two iStent inject micro-bypass stents
• Tobramycin
• Dexamethasone

Group Type: OTHER

Implantation of two iStent inject micro-bypass stents

Intervention Type: PROCEDURE

\- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).

Topical travoprost

Intervention Type: DRUG

\- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.

Two iStent inject micro-bypass stents

Intervention Type: DEVICE

\- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.

Tobramycin

Intervention Type: DRUG

Topical antibiotic (tobramycin):

1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .

Dexamethasone

Intervention Type: DRUG

Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):

• Week 1: 1 drop four (4) times per day in the study eye
• Week 2: 1 drop three (3) times per day in the study eye
• Week 3: 1 drop two (2) times per day in the study eye
• Week 4: 1 drop one (1) time per day in the study eye

Interventions

Implantation of two iStent inject micro-bypass stents

\- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).

Intervention Type: PROCEDURE

Topical travoprost

\- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.

Intervention Type: DRUG

Two iStent inject micro-bypass stents

\- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.

Intervention Type: DEVICE

Tobramycin

Topical antibiotic (tobramycin):

1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .

Intervention Type: DRUG

Dexamethasone

Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):

• Week 1: 1 drop four (4) times per day in the study eye
• Week 2: 1 drop three (3) times per day in the study eye
• Week 3: 1 drop two (2) times per day in the study eye
• Week 4: 1 drop one (1) time per day in the study eye

Intervention Type: DRUG

Other Intervention Names

iStent inject; travoprost; iStent inject

Eligibility Criteria

Inclusion Criteria

• Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
• Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
• C/D ratio ≤ 0.9
• Visual field defects, or nerve abnormality characteristic of glaucoma
• Two topical hypotensive medications at time of screening exam
• IOP > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam
• Study eye BCVA 20/100 or better
• Normal angle anatomy as determined by gonioscopy
• Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent

• Subject has completed appropriate medication washout
• Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period
• A 3mmHg IOP increase over screening mean IOP

Exclusion Criteria

• Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
• Prior stent implantations (study eye)
• Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
• Functionally significant visual field loss, including severe nerve fiber bundle defects
• Prior incisional glaucoma surgery
• Prior SLT within 90 days prior to screening
• Prior ALT
• Iridectomy or laser iridotomy
• Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
• Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
• Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata
• Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
• Corneal opacities that would inhibit visualization of the nasal angle
• Congenital or traumatic cataract
• Retinal or optic nerve disorders that are not associated with the existing glaucoma condition
• Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease
• Clinically significant sequelae from trauma
• Chronic ocular inflammatory disease or presence of active ocular inflammation

• Subject did not complete medication washout
• Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
• Subject does not have a 3mmHg IOP increase over screening mean diurnal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lilit Voskanyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

S.V. Malayan Eye Center

Locations

S.V. Malayan's Ophtalmology Centre

Yerevan, , Armenia

Countries

Armenia

References

Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.

Reference Type: BACKGROUND

PMID: 28384377 (View on PubMed)

Other Identifiers

GCF-039

Identifier Type: -

Identifier Source: org_study_id