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Evaluation of OT-135P (IOPtiMateTM) : Beam Manipulating System for CO2 Laser Assisted Non-Penetrating Glaucoma Surgery

NCT01059162 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-08

No results posted yet for this study

Summary

The aim of the study is to evaluate the safety and effectiveness of the IOPtiMate (OT-135P) in Laser Assisted Non-Penetrating Glaucoma surgery in Open-Angle and Pseudoexfoliative Glaucoma patients.

Conditions

Interventions

DEVICE

Laser Assisted Non-penetrating glaucoma surgery

A layer by Layer ablation of the deep sclera (under the superficial scleral flap) to achieve functional fluid percolation of the inner eye humor without penetration.

Sponsors & Collaborators

  • IOPtima Ltd.

    lead INDUSTRY

Principal Investigators

  • Noa Geffen, Dr. · Glaucoma service, Ophthalmology ward, Meir Hospital, Kfar-Saba

  • Shlomo Melamed, Dr. · Glaucoma service, Ophthalmology ward, Sheba Hospital, Tel-Hashomer Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01059162 on ClinicalTrials.gov