AquaLase® Liquefacture Device for Glaucoma

Not Applicable

• Conditions: Health Condition 1: null- Primary Open Angle Glaucoma

• Registration Number: CTRI/2009/091/001027
• Lead Sponsor: Alcon Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: 4

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 < IOP < 36 mmHg

8)If taking glaucoma medications, stable dose for 6 weeks and able to continue medications

throughout study

9)Phakic

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified