Assessing the Efficacy and Safety of Three iStent Inject W Implants With or Without Cataract Surgery For Patients With Glaucoma

Not Applicable

• Conditions: Primary or Secondary Open-angle Glaucoma; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12621000579897
• Lead Sponsor: Colin Clement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-17
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Pseudophakic or phakic (with cataract surgery for combined group)
2. Diagnosis of OAG, including primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), or pseudoexfoliative glaucoma (PXG).
3. Cup-to-Disc (C:D) ratio less than 0.9
4. VF defects with mean deviation ranging from 0 dB to -18dB (inclusive)
5. Mild, moderate, or severe glaucoma severity (per Hodapp-Anderson-Parrish grading scale based on preoperative VF MD)
6. Medicated or unmedicated IOP greater than 7 mmHg and less than 29 mmHg
7. Current treatment with 0 to 4 ocular hypotensive medications
8. Normal angle anatomy as determined by gonioscopy
9. Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stents
10. Planning to undergo or have undergone (within the prior 90 days) trabecular micro-bypass with three iStent inject W stents
11. Able and willing to attend follow-up exams for 12 (or 24) months
12. Able and willing to provide written informed consent

Exclusion Criteria

1. Traumatic, uveitic, neovascular, pigmentary, or angle-closure glaucoma; or glaucoma associated with vascular disorders
2. Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
3. Significant corneal dystrophy (e.g., bullous keratopathy, Fuch’s dystrophy), guttata, or opacities/disorders preventing angle visualization
4. Corneal surgery (prior or anticipated) of any type (e.g., LASIK, LASEK, PRK, PK, etc.) that may interfere with IOP measurement reliability
5. Angle closure or Shaffer grade < 2
6. Congenital or traumatic cataract
7. Retinal or optic nerve disorders not associated with glaucoma
8. Elevated episcleral venous pressure (e.g., thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital congestion)
9. Chronic or acute ocular inflammation (e.g., uveitis, iritis, retinitis)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure using Goldman applanation tonometry[At enrolment (pre-op baseline) then at the following intervals following surgery : day 1, week 1, month 1, month 3, month 6, month 12, month 18 and month 24. Primary end-points will be reported for 12-month and 24-month data.]