Primary Open Angle Glaucoma, CataractNCT02908633
Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract
A study testing canaloplasty and phacoemulsification in people with Primary Open Angle Glaucoma, 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 Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. 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
- Primary Open Angle Glaucoma, Cataract
- What is being tested?
- canaloplasty and phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Dec 2019
- 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: primary open angle glaucoma,
- eye with characteristic glaucoma changes (biomicroscopic,visual field)
- IOP over 21 mmHg after washout
- patients not tolerating antiglaucoma medications,
- patients with poor compliance
- progression in visual field
Who cannot join
- previous surgical glaucoma procedure
- previous cataract surgery
- BCVA under 0,004
- closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary)
- poorly controlled diabetes mellitus
- advanced AMD
Show all 9Show fewer
- active inflammatory disease
- pregnancy
- mental disease or emotional instability general steroid therapy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Military Institute of Medicine
Warsaw, 04-141
About this study
Official title: Comparison of Safety and Efficacy of Three Variants of Canaloplasty: Ab-externo, Ab-interno and Minicanaloplasty Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.
- Conditions
- Primary Open Angle Glaucoma, Cataract
- Being tested
- canaloplasty and phacoemulsification
- Keywords
- open angle glaucoma, canaloplasty, migs, abic
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canaloplasty and phacoemulsificationProcedure or surgery
Also called canaloplasty ab externo, canaloplasty ab interno, minicanaloplasty
| Study group | Role | What they receive |
|---|---|---|
| canaloplasty ab externo and phacoemulsification | Active comparator | As soon as the two scleral flaps: deep and superficial -similar to deep sclerectomy are dissected, the phacoemulsification with PCIOL insertion is performed. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and guided for 360 degrees within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. Then a suture is tied to the distal tip and the microcatheter is withdrawn. As it appears at the other ostium of canal the microcatheter it separated from the suture.Then suture loop is tightened to tension the trabecular meshwork. The superficial flap is sutured watertight to prevent bleb formation Receives: Procedure: canaloplasty and phacoemulsification |
| canaloplasty ab interno and phacoemulsification | Active comparator | This variant of canaloplasty spares conjunctival surface. First phacoemulsification and PCIOL placement is performed. The Schlemm's canal is reached through goniotomy through anterior chamber. Similarly microcatheter is inserted and viscodilatator applicated. The key difference, is that no tensioning suture is left after the catheter is withdrawn. phacoemulsification is performed. Receives: Procedure: canaloplasty and phacoemulsification |
| minicanaloplasty and phacoemulsification | Active comparator | The dissected conjunctival flap is of minimal size. The scleral flaps are sized: superficial flap 3x1mm, and deep flap: 1x1 mm- with no removal of the deep flap. Afterwards phacoemulsification part is performed. The microcatheterization and viscodilatation are conducted as in the traditional procedure.The conjunctiva is closed with one suture or coagulation Receives: Procedure: canaloplasty and phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean IOP
Measured: change form baseline at 24 months
Number of antiglaucoma drugs
Measured: change from baseline at 24 months
intraoperative complications
Measured: at the day of surgery
Secondary outcomes (4)
Best-Corrected Visual Acuity
Measured: change from baseline at 24 months
Visual Field changes
MD,
Measured: change from baseline at 24 months
Early and Late postsurgical complications
Measured: within 24 months
% IOP reduction
Measured: change at 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle Glaucoma, CataractStudies 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
- 90 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908633
- Sponsor's protocol ID
- 76/WIM/2015
- Other IDs
- 76/WIM/015
- Status last verified
- Sep 2016
- First submitted
- 17 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3.
PubMed 31377849
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Three Variants of Canaloplasty: Ab-externo, Ab-interno and Minicanaloplasty Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
- ClinicalTrials.gov ID
- NCT02908633
- Acronym / sponsor ID
- 76/WIM/2015
- Conditions
- Primary Open Angle Glaucoma, Cataract
- Keywords
- open angle glaucoma, canaloplasty, migs, abic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Sep 2016 (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 Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| canaloplasty ab externo and phacoemulsification | Active comparator | Procedure: canaloplasty and phacoemulsificationAs soon as the two scleral flaps: deep and superficial -similar to deep sclerectomy are dissected, the phacoemulsification with PCIOL insertion is performed. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and guided for 360 degrees within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. Then a suture is tied to the distal tip and the microcatheter is withdrawn. As it appears at the other ostium of canal the microcatheter it separated from the suture.Then suture loop is tightened to tension the trabecular meshwork. The superficial flap is sutured watertight to prevent bleb formation |
| canaloplasty ab interno and phacoemulsification | Active comparator | Procedure: canaloplasty and phacoemulsificationThis variant of canaloplasty spares conjunctival surface. First phacoemulsification and PCIOL placement is performed. The Schlemm's canal is reached through goniotomy through anterior chamber. Similarly microcatheter is inserted and viscodilatator applicated. The key difference, is that no tensioning suture is left after the catheter is withdrawn. phacoemulsification is performed. |
| minicanaloplasty and phacoemulsification | Active comparator | Procedure: canaloplasty and phacoemulsificationThe dissected conjunctival flap is of minimal size. The scleral flaps are sized: superficial flap 3x1mm, and deep flap: 1x1 mm- with no removal of the deep flap. Afterwards phacoemulsification part is performed. The microcatheterization and viscodilatation are conducted as in the traditional procedure.The conjunctiva is closed with one suture or coagulation |
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: primary open angle glaucoma,
- eye with characteristic glaucoma changes (biomicroscopic,visual field)
- IOP over 21 mmHg after washout
- patients not tolerating antiglaucoma medications,
Key exclusion criteria (9 listed)
- previous surgical glaucoma procedure
- previous cataract surgery
- BCVA under 0,004
- closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary)
- 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 phacoemulsificationAlso: canaloplasty ab externo, canaloplasty ab interno, minicanaloplasty | Procedure or surgery | canaloplasty ab externo and phacoemulsification, canaloplasty ab interno and phacoemulsification, minicanaloplasty and phacoemulsification |
Primary outcome
mean IOP
Time frame: change form baseline at 24 months
Number of antiglaucoma drugs
Time frame: change from baseline at 24 months
intraoperative complications
Time frame: at the day of surgery
4 secondary outcomes
Best-Corrected Visual Acuity
Time frame: change from baseline at 24 months
Visual Field changes
Time frame: change from baseline at 24 months
Early and Late postsurgical complications
Time frame: within 24 months
% IOP reduction
Time frame: change at 24 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 31377849Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3.
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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.
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 in people with Primary Open Angle Glaucoma, 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 21 Sep 2016. 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?
Contact Marek Rękas, MD, PhD, Professor (+48604113659, rekaspl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean IOP (time frame: change form baseline at 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908633, which also lists 1 linked publication.
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 21 Sep 2016.