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

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Glaukos

Status and phase

Completed
Phase 4

Conditions

Open-angle Glaucoma

Treatments

Drug: Dexamethasone
Drug: Tobramycin
Drug: Topical travoprost
Procedure: Implantation of two iStent inject micro-bypass stents
Device: Two iStent inject micro-bypass stents

Study type

Interventional

Funder types

Industry

Identifiers

NCT02873806
GCF-039

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Screening Exam 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

Baseline Exam Inclusion Criteria:

  • 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

Screening Exam 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

Baseline Exam Exclusion Criteria:

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

2 micro-bypass stents & travoprost
Other group
Description:
Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
Treatment:
Device: Two iStent inject micro-bypass stents
Procedure: Implantation of two iStent inject micro-bypass stents
Drug: Topical travoprost
Drug: Dexamethasone
Drug: Tobramycin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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