Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

NCT01456390 | Completed

• 1 other identifier: GCF-023
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Conditions

Open-Angle Glaucoma

Keywords

Open angle glaucoma; Prior trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP

  Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit

  12 Months

Secondary Outcomes (1)

• Mean diurnal IOP < 18mm Hg

  12 months

Other Outcomes (1)

• Safety/adverse event monitoring

  0-61 months

Study Arms (1)

iStent and iStent supra

OTHER

Implantation of two iStent devices and one iStent supra device

Device: iStent and iStent supra

Interventions

iStent and iStent supra DEVICE

Implantation of two iStent devices and one iStent supra device

iStent and iStent supra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
• Open-angle glaucoma (including pseudoexfoliative)

You may not qualify if:

• Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
• Prior ALT
• Prior SLT within 90 days of screening visit

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

S.V. Malayan Ophthalmological Center

Yerevan, 0001, Armenia

Location

Related Publications (1)

• 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.

  PMID: 29476443 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Lilit A Voskanyan, MD, PhD

  S.V. Malayan Ophthalmological Center, Yerevan, Armenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 20, 2011
• Study Start: September 1, 2011
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

AR (1)