Health Condition 1: null- Primary Open Angle Glaucoma
Conditions
Interventions
Intervention1: Evaluation of the Safety of AquaLase®
Liquefacture Device Treatment of the Trabecular Meshwork: AquaLase®
Liquefaction Device Capsule Washing Tip
with BSS®
Study Dosage / Usage: 300-360°
of trabecular meshwork in two (2) 60 second
increments
Control Intervention1: NIL: NIL
Sponsors
Alcon Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)At least 18 years old and of legal age to consent 2)Able and willing to sign informed consent form 3)Able, healthy and willing to attend follow-up visits for 1 month after procedure 4)Best corrected visual acuity worse than or equal to 6/120 (20/400) in study eye 5)Best corrected visual acuity better than or equal to 6/60 (20/200) in fellow eye 6)Permanent non-recoverable vision loss in study eye due to POAG and/or ARMD 7)Grade III or IV Schaeffer Scale open angle on gonioscopy, without PAS or recession 12 mmHg 8)If taking glaucoma medications, stable dose for 6 weeks and able to continue medications throughout study 9)Phakic
Exclusion criteria
Exclusion criteria: 1)Any prior intraocular or refractive surgery 2)Any form of glaucoma other than Primary Open Angle Glaucoma 3)Primary or secondary angle closure 4)Limited or obstructed view of angle, cornea or fundus preventing application of therapy or required observations / measurements 5)Any angle with PAS or new vessels on gonioscopy Corneal abnormalities, including Fuch?s Dystrophy, that would preclude accurate IOP readings by applanation tonometery and specular microscopy 6)Uncontrolled systemic disease based on medical history 7)Central Corneal Endothelial Cell Count 1800 cells / mm2 8)Any other active or recently resolved ocular disease, e.g., uveitis or ocular infection 9)History of persistent or recurring ocular inflammation 10)Any current, clinically significant, progressive retinal disease including pre-proliferative or proliferative diabetic retinopathy 11)Any current or past use of any alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1 A adrenoceptor, such as Flomax®, Cardura®, or Hytrin® 12)Known hypersensitivity to any treatment component of this procedure 13)Women who are pregnant, intend to become pregnant during the study period, are not using highly effective birth control measures or are breast-feeding 14)Current participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary statistical objective of this study is to describe the ocular safety associated with the AquaLase® Liquefaction Device. The pass/fail criterion is that all eyes meet the safety performance measures.Descriptive summary of safety variables including inflammation, infection, endothelial cell density, hyphema, iris trauma, corneal complications, retinal complications, choroidal complications, lens trauma, any additional device or non-device related ocular adverse event associated with the treatment procedure.Timepoint: This study is a single arm, open-label, unilateral study investigating the safety of the AquaLase® Liquefaction Device Capsule Washing Tip BSS® treatment on the trabecular meshwork of four eyes in patients 18 years of age and older at Aravind Hospital, Pondicherry, India. There are six (6) scheduled visits that occur at the following time points: Baseline / Pre-Surgery Surgery 1 Day Post-Surgery 7 Day Post-Surgery 14 Day Post-Surgery 1 Month Post-Surgery (Exit Visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Salman Anzer
Outcome results
None listed