Open Angle GlaucomaNCT01726543
Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
A study testing Canaloplasty and phacoemulsification and Non-penetrating deep sclerectomy and phacoemulsification in people with Open Angle Glaucoma and Cataract, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Open Angle Glaucoma, Cataract
- What is being tested?
- Canaloplasty and phacoemulsification and Non-penetrating deep sclerectomy and phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2011to Dec 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- co-existing glaucoma and cataract
- glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
- eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP >16mmHg on medication or without, or IOP<16mmHg on 2 or more medications.
- uncontrolled IOP
- patients not tolerating antiglaucoma medications,
- patients with poor compliance
- progression in visual field
Who cannot join
- previous surgical glaucoma procedure
- previous cataract surgery
- visual function under 0,004
- closed angle glaucoma
- poorly controlled diabetes mellitus
- advanced AMD
Show all 9Show fewer
- active inflammatory disease
- pregnancy
- mental disease or emotional instability, that could
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Military Institute of Medicine
Warsaw, 04-141
Anna Byszewska, MD, 500285890 ext. +48, ania.byszewska@gmail.com
Marek Rekas, MD, PhD Associate Professor of, 226816575 ext. +48, rekaspl@gmail.com
About this study
Official title: Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.
- Conditions
- Open Angle Glaucoma, Cataract
- Being tested
- Canaloplasty and phacoemulsification, Non-penetrating deep sclerectomy and phacoemulsification
- Keywords
- canaloplasty, non-penetrating deep sclerectomy, glaucoma, cataract, ophthalmology, glaucoma surgery
- Medical subject headings
- Glaucoma, Open-Angle, Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canaloplasty and phacoemulsificationProcedure or surgery
As soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation.
Non-penetrating deep sclerectomy and phacoemulsificationProcedure or surgery
A fornix-based conjunctival flap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral flap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral flap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral flap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner.
| Study group | Role | What they receive |
|---|---|---|
| Canaloplasty and phacoemulsification | Active comparator | Not described Receives: Procedure: Canaloplasty and phacoemulsification |
| Non-penetrating deep sclerectomy and phacoemulsification | Active comparator | Not described Receives: Procedure: Non-penetrating deep sclerectomy and phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
by Goldman tonometry
Primary efficacy outcome-proportion of the population that achieves an IOP of >5 and ≤ 21 mmHg, irrespective of glaucoma medication use.
Complete success is defined as achieving the target IOP without use of medications.
A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively.
Measured: Change from Baseline at 24months
number of antiglaucoma medications
Measured: Change from Baseline at 24months
visual acuity
ETDRS chart
Measured: Change from Baseline at 24months
intraoperative complications
Rates for surgical complications and adverse events
Measured: surgery day
Secondary outcomes (2)
Secondary procedures
Any additional ophtalmic surgical procedures that need to be done within the time frame.
Measured: within 24 months
Early and late complications
complications and Adverse effects rate
Measured: within 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Rekas, Military Institute od Medicine National Research Institute
- Investigators
- Marek Rekas, MD,PhD,Professor, Study director, Military Institute od Medicine National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726543
- Sponsor's protocol ID
- BW1 151/12
- Other IDs
- BW1151/12
- Status last verified
- Nov 2012
- First submitted
- 17 Apr 2012
- Last updated
- 15 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
- ClinicalTrials.gov ID
- NCT01726543
- Acronym / sponsor ID
- BW1 151/12
- Conditions
- Open Angle Glaucoma, Cataract
- Keywords
- canaloplasty, non-penetrating deep sclerectomy, glaucoma, cataract, ophthalmology, glaucoma surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Nov 2012 (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.
It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canaloplasty and phacoemulsification | Active comparator | Procedure: Canaloplasty and phacoemulsification |
| Non-penetrating deep sclerectomy and phacoemulsification | Active comparator | Procedure: Non-penetrating deep sclerectomy and phacoemulsification |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- co-existing glaucoma and cataract
- glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
- eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP >16mmHg on medication or without, or IOP<16mmHg on 2 or more medications.
- uncontrolled IOP
- patients not tolerating antiglaucoma medications,
Key exclusion criteria (9 listed)
- previous surgical glaucoma procedure
- previous cataract surgery
- visual function under 0,004
- closed angle glaucoma
- poorly controlled diabetes mellitus
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 |
|---|---|---|
| Canaloplasty and phacoemulsificationAs soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation. | Procedure or surgery | Canaloplasty and phacoemulsification |
| Non-penetrating deep sclerectomy and phacoemulsificationA fornix-based conjunctival flap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral flap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral flap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral flap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner. | Procedure or surgery | Non-penetrating deep sclerectomy and phacoemulsification |
Primary outcome
IOP
Time frame: Change from Baseline at 24months
by Goldman tonometry Primary efficacy outcome-proportion of the population that achieves an IOP of >5 and ≤ 21 mmHg, irrespective of glaucoma medication use. Complete success is defined as achieving the target IOP without use of medications. A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively.
number of antiglaucoma medications
Time frame: Change from Baseline at 24months
visual acuity
Time frame: Change from Baseline at 24months
ETDRS chart
intraoperative complications
Time frame: surgery day
Rates for surgical complications and adverse events
2 secondary outcomes
Secondary procedures
Time frame: within 24 months
Early and late complications
Time frame: within 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
Related trials for Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Marek Rekas, MD,PhD,Professor study director
Military Institute od Medicine National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canaloplasty and phacoemulsification and Non-penetrating deep sclerectomy and phacoemulsification in people with Open Angle Glaucoma and Cataract, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 7 inclusion and 9 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 15 Nov 2012. 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: Change from Baseline at 24months). The study lists 4 primary outcomes in all. 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 15 Nov 2012.