GlaucomaNCT03894631
Effect of Intra-subject Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intraocular Pressure
A study testing KDB/Phacoemulsification and Trabectome/Phacoemulsification in people with Glaucoma, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
To determine the safety and efficacy of Kahook dual blade over Trabectome in lowering intraocular pressure in glaucoma patients. Glaucoma surgery will be performed in conjunction with cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- KDB/Phacoemulsification and Trabectome/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 siteUnited States
- Study dates
- 6 Mar 2019to 9 Nov 2023
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age ≥18 years old
- Patients already diagnosed with Glaucoma and Cataract in both eyes
- Patients with Primary open angle glaucoma (POAG), Low-tension glaucoma (LTG), Pseudoexfoliation glaucoma (PSXF), pigmentary glaucoma and other glaucoma types with a structurally-normal looking open angle in both eyes
- Glaucoma that is inadequately controlled on medical therapy or with the need to reduce the glaucoma medication burden
- Patients with a visually-significant cataract in both eyes
- Patients that could benefit from cataract removal combined with MIGS surgery in both eyes
Who cannot join
- Patients age less than 18 years
- Women of child bearing age
- Patients unable or unwilling to provide informed consent to participate in the study
- Aphakic and Pseudophakic patients
- Patients with primary open angle glaucoma with previously failed trabeculectomy or other glaucoma aqueous drainage surgical procedures
- Patients with a closed angle, angle neovascularization (NVG), traumatic glaucoma, or any other angle abnormality in either eye
- Patients potentially unavailable for follow up visits for the length of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ira G. Ross Eye Institute
Buffalo, New York, 14209
About this study
Official title: Intra-subject Comparison Between the Effect of Combined Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intra Ocular Pressure and Other Surgical Outcomes
To determine the safety and efficacy of Kahook dual blade over Trabectome in lowering intraocular pressure in glaucoma patients. Glaucoma surgery will be performed in conjunction with cataract surgery. The investigators hypothesize that the Kahook dual blade is as effective as Trabectome in lowering intra-ocular pressure (IOP), and as safe with a similar rate of post-operative complications such as hyphema.
Read the detailed description
Trabectome is a type of Minimally Invasive Glaucoma Surgery (MIGS) where the Trabectome handpiece tip uses electrical current to cauterized and remove a strip of trabecular meshwork and the roof of Schlemm's canal to ease the outflow of aqueous. Kahook Dual Blade (KDB) procedure is another type of MIGS where the dual blade is used to remove the trabecular meshwork and Schlemm's canal roof to increase the aqueous outflow but without any cauterization.
Preclinical studies have evaluated the clinical outcome of Trabectome over KDB. Though Trabectome helps to lower IOP, it may remove only a portion of trabecular meshwork and possibly cause damage to surrounding tissue with leaflets of residual remaining tissue that may cause blockage of aqueous drainage. Unlike Trabectome, the KDB removes blocks of trabecular meshwork with no residual tissue leaflets, low rate of fibrosis, no damage to the surrounding tissue and lower cost. However, research studies have shown that although the Trabectome and KDB have different surgical techniques and both have surgical related risks as in any glaucoma surgery, the post-surgical clinical outcome and safety profile of Trabectome could be favorable to the KDB technique.
Few studies have evaluated the clinical outcome of Trabectome over Trabeculectomy, while few other studies evaluated Trabectome over phaco-trabectome. Some studies evaluated the clinical outcome of Trabectome alone while other studies assessed the outcome of KDB alone. Some other studies compared KDB with iStent while another study compared Trabectome versus KDB in porcine eye perfusion model. Studies have also shown that Trabectome, when combined with phaco has a higher success rate than Trabectome alone. However, due to the infancy of KDB procedure, there are no robust prospective comparison studies comparing the clinical outcome of KDB over Trabectome when combined with phacoemulsification. The aim of the study is to systematically compare the clinical outcomes of KDB over Trabectome in treating glaucoma
- Conditions
- Glaucoma
- Being tested
- KDB/Phacoemulsification, Trabectome/Phacoemulsification
- Keywords
- Kahook dual blade, Trabectome, Intraocular Pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDB/PhacoemulsificationProcedure or surgery
50 eyes of 50 patients will receive combined KDB/phaco surgery
Trabectome/PhacoemulsificationProcedure or surgery
The contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery
| Study group | Role | What they receive |
|---|---|---|
| Phaco/KDB | Active comparator | Eyes needing glaucoma and cataract extraction will receive combined KDB and phacoemulsification in one eye of a patient Receives: Procedure: KDB/Phacoemulsification |
| Phaco/Trabectome | Active comparator | Contralateral eyes needing glaucoma and cataract extraction will receive combined Trabectome and phacoemulsification in contralateral eye of the same patient Receives: Procedure: Trabectome/Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intraocular pressure measurements between baseline and postoperative followup visits
Baseline (pre-operative condition) and post operative intraocular pressure will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.
Measured: 2 years
Secondary outcomes (3)
Changes in visual acuity measurements measured using a Snellen Vision Chart between baseline and postoperative followup visits
Baseline (pre-operative condition) and post operative visual acuity will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.
Measured: 2 years
Changes in number of medications between baseline and postoperative followup visits
Baseline (pre-operative condition) and post operative number of medications list will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.
Measured: 2 years
Rate of post surgical complications
Rate of post surgical complications such as Hypotony, Corneal Edema, Hyphema, Iritis, Vitreous Hemorrhage and Cystoid Macular Edema.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start6 Mar 2019
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asher Weiner, MD, State University of New York at Buffalo
- Investigators
- Asher Weiner, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894631
- Sponsor's protocol ID
- STUDY00002910
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2019
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-subject Comparison Between the Effect of Combined Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intra Ocular Pressure and Other Surgical Outcomes
- ClinicalTrials.gov ID
- NCT03894631
- Acronym / sponsor ID
- STUDY00002910
- Conditions
- Glaucoma
- Keywords
- Kahook dual blade, Trabectome, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 28 Mar 2019 (actual)
- 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.
To determine the safety and efficacy of Kahook dual blade over Trabectome in lowering intraocular pressure in glaucoma patients. Glaucoma surgery will be performed in conjunction with cataract surgery. The investigators hypothesize that the Kahook dual blade is as effective as Trabectome in lowering intra-ocular pressure (IOP), and as safe with a similar rate of post-operative complications such as hyphema.
Detailed description
Trabectome is a type of Minimally Invasive Glaucoma Surgery (MIGS) where the Trabectome handpiece tip uses electrical current to cauterized and remove a strip of trabecular meshwork and the roof of Schlemm's canal to ease the outflow of aqueous. Kahook Dual Blade (KDB) procedure is another type of MIGS where the dual blade is used to remove the trabecular meshwork and Schlemm's canal roof to increase the aqueous outflow but without any cauterization.
Preclinical studies have evaluated the clinical outcome of Trabectome over KDB. Though Trabectome helps to lower IOP, it may remove only a portion of trabecular meshwork and possibly cause damage to surrounding tissue with leaflets of residual remaining tissue that may cause blockage of aqueous drainage. Unlike Trabectome, the KDB removes blocks of trabecular meshwork with no residual tissue leaflets, low rate of fibrosis, no damage to the surrounding tissue and lower cost. However, research studies have shown that although the Trabectome and KDB have different surgical techniques and both have surgical related risks as in any glaucoma surgery, the post-surgical clinical outcome and safety profile of Trabectome could be favorable to the KDB technique.
Few studies have evaluated the clinical outcome of Trabectome over Trabeculectomy, while few other studies evaluated Trabectome over phaco-trabectome. Some studies evaluated the clinical outcome of Trabectome alone while other studies assessed the outcome of KDB alone. Some other studies compared KDB with iStent while another study compared Trabectome versus KDB in porcine eye perfusion model. Studies have also shown that Trabectome, when combined with phaco has a higher success rate than Trabectome alone. However, due to the infancy of KDB procedure, there are no robust prospective comparison studies comparing the clinical outcome of KDB over Trabectome when combined with phacoemulsification. The aim of the study is to systematically compare the clinical outcomes of KDB over Trabectome in treating glaucoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phaco/KDB | Active comparator | Procedure: KDB/PhacoemulsificationEyes needing glaucoma and cataract extraction will receive combined KDB and phacoemulsification in one eye of a patient |
| Phaco/Trabectome | Active comparator | Procedure: Trabectome/PhacoemulsificationContralateral eyes needing glaucoma and cataract extraction will receive combined Trabectome and phacoemulsification in contralateral eye of the same patient |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients age ≥18 years old
- Patients already diagnosed with Glaucoma and Cataract in both eyes
- Patients with Primary open angle glaucoma (POAG), Low-tension glaucoma (LTG), Pseudoexfoliation glaucoma (PSXF), pigmentary glaucoma and other glaucoma types with a structurally-normal looking open angle in both eyes
- Glaucoma that is inadequately controlled on medical therapy or with the need to reduce the glaucoma medication burden
- Patients with a visually-significant cataract in both eyes
Key exclusion criteria (7 listed)
- Patients age less than 18 years
- Women of child bearing age
- Patients unable or unwilling to provide informed consent to participate in the study
- Aphakic and Pseudophakic patients
- Patients with primary open angle glaucoma with previously failed trabeculectomy or other glaucoma aqueous drainage surgical procedures
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 |
|---|---|---|
| KDB/Phacoemulsification50 eyes of 50 patients will receive combined KDB/phaco surgery | Procedure or surgery | Phaco/KDB |
| Trabectome/PhacoemulsificationThe contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery | Procedure or surgery | Phaco/Trabectome |
Primary outcome
Changes in intraocular pressure measurements between baseline and postoperative followup visits
Time frame: 2 years
Baseline (pre-operative condition) and post operative intraocular pressure will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.
3 secondary outcomes
Changes in visual acuity measurements measured using a Snellen Vision Chart between baseline and postoperative followup visits
Time frame: 2 years
Changes in number of medications between baseline and postoperative followup visits
Time frame: 2 years
Rate of post surgical complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
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)
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.
Asher Weiner, MD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KDB/Phacoemulsification and Trabectome/Phacoemulsification in people with Glaucoma, run by State University of New York at Buffalo at 1 site in United States.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jul 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in intraocular pressure measurements between baseline and postoperative followup visits (time frame: 2 years). 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 30 Jul 2024.