MINIMALLY INVASIVE PROCEDURE FOR GLAUCOMA TREATMENT

Phase 1

Suspended

• Conditions: Health Condition 1: H401- Open-angle glaucoma

• Registration Number: CTRI/2019/08/020913
• Lead Sponsor: Appasamy Ocular Devices Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Male or female � 18 years

Primary open-angle Glaucoma, pseudoexfoliation Glaucoma or pigmentary Glaucoma in the study eye (EGS criteria)

Optic nerve appearance characteristic of Glaucoma in the study eye

Patient is treated with 0 to 5 hypotensive medications in the study eye

Unsatisfactory IOP ( >21 mmHg) at the screening visit in the study eye

If cataract is not present - Shaffer grade � III in all four angle quadrants in the study eye

Subject is able and willing to attend all scheduled follow-up exams

Subject understands and signs the informed consent

Exclusion Criteria

Ocular conditions with a poorer prognosis in the fellow eye than in the study eye

Closed angle forms of Glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMS�® procedure or the study eye is pseudophakic with PCIOL.

Congenital or developmental Glaucoma in either eye

Other secondary Glaucoma (such as neovascular, uveitic, lens- induced, trauma-induced, or Glaucoma associated with increased episcleral venous pressure) in the study eye

Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye

Subject has history of penetrating keratoplasty (PKP)

Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic.

Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements

Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemmââ?¬•s canal in the study eye.

Best-correctedvisualacuityworsethan20/40(Snellen equivalent) in the fellow eye

History of idiopathic or autoimmune uveitis in either eye

Severe trauma in study eye

active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for Glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period

Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye

Aphakia

Prior vitreoretinal surgery in study eye

Clinically significant ocular inflammation or infection within 90 days prior to screening

Unable to discontinue use of blood thinners in accordance with surgeonââ?¬•s standard preoperative instructions

Uncontrolled systemic disease that in the opinion of the investigator would put the subjectââ?¬•s health at risk and/or prevent the subject from completing all study visits

Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit

Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified