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

NCT01059162 | Unknown

• 1 other identifier: PCL-34-003 (03)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Open Angle Glaucoma; Pseudo-Exfoliative Glaucoma

Keywords

Glaucoma Surgery; Filtering Surgery; Non Penetrating glaucoma surgery

Outcome Measures

Primary Outcomes (1)

• Intra-Ocular Pressure (IOP)

  6 months

Secondary Outcomes (1)

• Number of anti-Glaucoma Medications

  6 months

Study Arms (1)

IOPtiMate

EXPERIMENTAL

patients will undergo non-penetrating laser assisted filtering surgery by the IOPtiMate (OT-134) system

Device: Laser Assisted Non-penetrating glaucoma surgery

Interventions

Laser Assisted Non-penetrating glaucoma surgery DEVICE

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.

IOPtiMate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 18 years of age or older.
• Patient must have primary open angle glaucoma or pseudo-exfoliative glaucoma in the study eye; diagnosis is based on glaucomatous optic neuropathy, Shaffer angle of +2 and visual field defect attributed to glaucoma (at least two consecutive abnormal visual field test results, defined as a pattern SD (PSD) outside the 95% normal confidence limits and/or glaucoma Hemifield Test (Carl Zeiss Meditec, Inc.).
• Eye to be treated must be phakic or pseudophakic eye with no ocular disorder or ocular diseases but cataract, and no prior surgical intervention in study eye but cataract surgery with clear corneal incision and trabeculoplasty performed \> 3 months ago.
• Patient is indicated for filtration surgery.
• Presence of ocular hypertension, defined as an intraocular corrected pressure (IOP) ≥ 21 mm Hg in the study eye, while on maximal tolerated medications . This IOP level of above or equal 21 mmHg must be verified and recorded in the most recent 2 consecutive measurements (but not taken on the same day) prior to operation.
• Best corrected visual acuity (BCVA) better than 20/200 in the fellow eye.
• Optic neuropathy is attributed exclusively to glaucoma.
• Patient or legal guardian agrees to sign written informed consent prior to study participation.
• Patient is able and willing to complete post-operative follow-up requirements.

You may not qualify if:

• Patient has previously undergone a non-penetrating glaucoma surgery with the IOPtima CO2 Laser System in fellow eye.
• Diagnosis of glaucoma other than primary open angle glaucoma or pseudo-exfoliative glaucoma.
• History of previous intraocular surgery in the study eye; referring to but not limited to glaucoma filtering surgery (penetrating and non-penetrating), laser gonioplasty, corneal transplant, and history of any other laser ocular procedures except for laser trabeculoplasty surgery.
• Laser trabeculoplasty surgery within the last three months in the study eye.
• Study eye is aphakic.
• Patients with previous cataract extraction with scleral tunnel and or conjunctival incision in the study eye.
• Proliferative or severe non-proliferative retinopathy in either eye.
• Eyes with (dilated) pupil diameter of less than 2 mm in the study eye.
• Discernable congenital anomaly of the anterior chamber angle in the study eye.
• Patients with neuropathy other than glaucoma in the study eye.
• Patient with RVO (retinal vein occlusion) in the study eye.
• Patient with RAO (retinal artery occlusion) in the study eye.
• History of prior vitrectomy or Vitreous Hemorrhage (VH) in the study eye.
• Patient with media opacification which may interfere with optic nerve evaluation in the study eye.
• Patient with a history of severe eye trauma in the study eye

Sponsors & Collaborators

• IOPtima Ltd.: lead

Study Sites (1)

Ophthalmology ward, Meir Hospital

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Noa Geffen, Dr.

  Glaucoma service, Ophthalmology ward, Meir Hospital, Kfar-Saba

  PRINCIPAL INVESTIGATOR

• Shlomo Melamed, Dr.

  Glaucoma service, Ophthalmology ward, Sheba Hospital, Tel-Hashomer Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

IL (1)