Open Angle GlaucomaNCT01059162
Evaluation of OT-135P (IOPtiMateTM) : Beam Manipulating System for CO2 Laser Assisted Non-Penetrating Glaucoma Surgery
A study testing Laser Assisted Non-penetrating glaucoma surgery in people with Open Angle Glaucoma and Pseudo-Exfoliative Glaucoma, run by IOPtima Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Pseudo-Exfoliative Glaucoma
- What is being tested?
- Laser Assisted Non-penetrating glaucoma surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- Patient with ocular malformations such as microphthalmia in the study eye.
- Patient with concurrent inflammatory / infective eye disorder (e.g. episcleritis, scleritis) in the study eye
- Patient with any sign of past or present uveitis (anterior / posterior)
- Patient with known allergy to the study medications.
- Patient with severe systemic disease or disabling conditions such as: chronic renal failure requiring dialysis, severe and disenabling neurological disease, and post organ transplants.
- Patient participating in another clinical trial or participation in another clinical trial is < 3 months.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Laser Assisted Non-penetrating glaucoma surgery
- Keywords
- Glaucoma Surgery, Filtering Surgery, Non Penetrating glaucoma surgery
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Assisted Non-penetrating glaucoma surgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IOPtiMate | Experimental | patients will undergo non-penetrating laser assisted filtering surgery by the IOPtiMate (OT-134) system Receives: Device: Laser Assisted Non-penetrating glaucoma surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Ocular Pressure (IOP)
Measured: 6 months
Secondary outcomes (1)
Number of anti-Glaucoma Medications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IOPtima Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Noa Geffen, Dr., Principal investigator, Glaucoma service, Ophthalmology ward, Meir Hospital, Kfar-SabaShlomo Melamed, Dr., Principal investigator, Glaucoma service, Ophthalmology ward, Sheba Hospital, Tel-Hashomer Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059162
- Sponsor's protocol ID
- PCL-34-003 (03)
- Status last verified
- Jun 2011
- First submitted
- 28 Jan 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OT-135P (IOPtiMateTM) : Beam Manipulating System for CO2 Laser Assisted Non-Penetrating Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT01059162
- Acronym / sponsor ID
- PCL-34-003 (03)
- Conditions
- Open Angle Glaucoma, Pseudo-Exfoliative Glaucoma
- Keywords
- Glaucoma Surgery, Filtering Surgery, Non Penetrating glaucoma surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IOPtima Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOPtiMate | Experimental | Device: Laser Assisted Non-penetrating glaucoma surgerypatients will undergo non-penetrating laser assisted filtering surgery by the IOPtiMate (OT-134) system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Assisted Non-penetrating glaucoma surgeryA 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. | Device | IOPtiMate |
Primary outcome
Intra-Ocular Pressure (IOP)
Time frame: 6 months
1 secondary outcome
Number of anti-Glaucoma Medications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noa Geffen, Dr. principal investigator
Glaucoma service, Ophthalmology ward, Meir Hospital, Kfar-Saba
Shlomo Melamed, Dr. principal investigator
Glaucoma service, Ophthalmology ward, Sheba Hospital, Tel-Hashomer Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Assisted Non-penetrating glaucoma surgery in people with Open Angle Glaucoma and Pseudo-Exfoliative Glaucoma, run by IOPtima Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-Ocular Pressure (IOP) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.