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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059162
Recruitment Status : Unknown
Verified June 2011 by IOPtima Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2010
Last Update Posted : June 8, 2011
Information provided by:
IOPtima Ltd.

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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Pseudo-Exfoliative Glaucoma Device: Laser Assisted Non-penetrating glaucoma surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of OT-135P (IOPtiMateTM) : Beam Manipulating System for CO2 Laser Assisted Non-Penetrating Glaucoma Surgery
Study Start Date : April 2010
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: IOPtiMate
patients will undergo non-penetrating laser assisted filtering surgery by the IOPtiMate (OT-134) system
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.

Primary Outcome Measures :
  1. Intra-Ocular Pressure (IOP) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of anti-Glaucoma Medications [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must be 18 years of age or older.
  2. 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.).
  3. 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.
  4. Patient is indicated for filtration surgery.
  5. 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.
  6. Best corrected visual acuity (BCVA) better than 20/200 in the fellow eye.
  7. Optic neuropathy is attributed exclusively to glaucoma.
  8. Patient or legal guardian agrees to sign written informed consent prior to study participation.
  9. Patient is able and willing to complete post-operative follow-up requirements.

Exclusion Criteria:

  1. Patient has previously undergone a non-penetrating glaucoma surgery with the IOPtima CO2 Laser System in fellow eye.
  2. Diagnosis of glaucoma other than primary open angle glaucoma or pseudo-exfoliative glaucoma.
  3. 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.
  4. Laser trabeculoplasty surgery within the last three months in the study eye.
  5. Study eye is aphakic.
  6. Patients with previous cataract extraction with scleral tunnel and or conjunctival incision in the study eye.
  7. Proliferative or severe non-proliferative retinopathy in either eye.
  8. Eyes with (dilated) pupil diameter of less than 2 mm in the study eye.
  9. Discernable congenital anomaly of the anterior chamber angle in the study eye.
  10. Patients with neuropathy other than glaucoma in the study eye.
  11. Patient with RVO (retinal vein occlusion) in the study eye.
  12. Patient with RAO (retinal artery occlusion) in the study eye.
  13. History of prior vitrectomy or Vitreous Hemorrhage (VH) in the study eye.
  14. Patient with media opacification which may interfere with optic nerve evaluation in the study eye.
  15. Patient with a history of severe eye trauma in the study eye
  16. Patient with ocular malformations such as microphthalmia in the study eye.
  17. Patient with concurrent inflammatory / infective eye disorder (e.g. episcleritis, scleritis) in the study eye
  18. Patient with any sign of past or present uveitis (anterior / posterior)
  19. Patient with known allergy to the study medications.
  20. Patient with severe systemic disease or disabling conditions such as: chronic renal failure requiring dialysis, severe and disenabling neurological disease, and post organ transplants.
  21. Patient participating in another clinical trial or participation in another clinical trial is < 3 months.
  22. Patient is pregnant or breast feeding. Women of child bearing age will submit a urine sample result for β-HCG (Pregnancy test) within 2 weeks of surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059162

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Ophthalmology ward, Meir Hospital
Kfar-Saba, Israel
Sponsors and Collaborators
IOPtima Ltd.
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Principal Investigator: 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

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Responsible Party: Dan Peres, COO, IOPtima Ltd. Identifier: NCT01059162     History of Changes
Other Study ID Numbers: PCL-34-003 (03)
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by IOPtima Ltd.:
Glaucoma Surgery
Filtering Surgery
Non Penetrating glaucoma surgery

Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases