Clinical Evaluation of the AqueSys Implant for the Treatment of ocular hypertension and open angle glaucoma

Clinical evaluation of the safety and effectiveness of the AqueSys implant in participants with poorly controlled intraocular pressure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000021077

Enrollment

Registered

2010-01-08

Start date

2009-11-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of the study is to evaluate the safety and effectiveness of the AqueSys Implant for the treatment of ocular hypertension and open angle glaucoma.

Interventions

The AqueSys Implant is implanted in the eye and is intended for the treatment of open angle glaucoma and ocular hypertension. The preloaded needle is inserted through the cornea and the needle is directed across the anterior chamber and implanted in the target quadrant of the eye. The implantation procedure will take approximately 30 minutes. The implant will remain permanently or until it is removed.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects with poorly controlled intraocular pressure.

Exclusion criteria

1. Angle Closure Glaucoma 2. Congenital or other secondary glaucomas developed as a complication of other medical conditions

Outcome results