GlaucomaNCT04476810
Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
A study testing kahook dual blade in people with Glaucoma and Glaucoma, Open-Angle, run by Ahmed Al Habash at 1 site in Saudi Arabia.
Trial summary
Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous goniosynechialysis in cases of angle-closure glaucoma, by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle, Cataract
- What is being tested?
- kahook dual blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2017to 30 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults 18 years or older
- medically-managed glaucoma
- visually significant cataract
Who cannot join
- Patients undergoing any other combined procedures
- active uveitis
- coexisting retinopathy that limits visual acuity potential
- active neovascularization
- angle dysgenesis
- those with less than 6 months of follow-up, were excluded.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Imam Abdulrahman Bin Faisal University Hospital
Dammam
About this study
Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King Fahd Hospital of the University, Dammam, Saudi Arabia.
Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Cataract, Angle Closure Glaucoma, Surgery
- Being tested
- kahook dual blade
- Keywords
- glaucoma, goniotomy, Kahook Dual Blade, combined phacoemulsification, MIGS, Schlemm's Canal
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Cataract, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kahook dual bladeDevice
Also called phacoemulsification
Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade
| Study group | Role | What they receive |
|---|---|---|
| combined (phaco-kdb) | Experimental | Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed. Receives: Device: kahook dual blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Characterize changes in intraocular pressure (IOP) in mmHg goldmann applanation tonometry each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade.
Measured: 36 months
Intraocular pressure lowering medications
count the change in number of Intraocular pressure lowering medications each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade
Measured: 36 months
Secondary outcomes (1)
Visual acuity
Characterize visual acuity (VA) using logMAR chart, each visit in clinic post undergoing combined phacoemulsification and excisional goniotomy with the kahook dual blade.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jan 2017
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
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.
- 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
- Model description
- Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Al Habash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Al Habash, Imam Abdulrahman Bin Faisal University
- Investigators
- Ahmed Al habash, MD, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476810
- Sponsor's protocol ID
- IRB -2020-01-169
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
- ClinicalTrials.gov ID
- NCT04476810
- Acronym / sponsor ID
- IRB -2020-01-169
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Cataract, Angle Closure Glaucoma, Surgery
- Keywords
- glaucoma, goniotomy, Kahook Dual Blade, combined phacoemulsification, MIGS, Schlemm's Canal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ahmed Al HabashUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 20 Jul 2020 (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.
Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King Fahd Hospital of the University, Dammam, Saudi Arabia.
Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
| Arm | Type | Receives |
|---|---|---|
| combined (phaco-kdb) | Experimental | Device: kahook dual bladeProspective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults 18 years or older
- medically-managed glaucoma
- visually significant cataract
Key exclusion criteria (6 listed)
- Patients undergoing any other combined procedures
- active uveitis
- coexisting retinopathy that limits visual acuity potential
- active neovascularization
- angle dysgenesis
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 |
|---|---|---|
| kahook dual bladeAlso: phacoemulsificationCombined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade | Device | combined (phaco-kdb) |
Primary outcome
Intraocular pressure
Time frame: 36 months
Characterize changes in intraocular pressure (IOP) in mmHg goldmann applanation tonometry each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade.
Intraocular pressure lowering medications
Time frame: 36 months
count the change in number of Intraocular pressure lowering medications each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade
1 secondary outcome
Visual acuity
Time frame: 36 months
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 29 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Al habash, MD principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kahook dual blade in people with Glaucoma and Glaucoma, Open-Angle, run by Ahmed Al Habash at 1 site in Saudi Arabia.
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 3 inclusion and 6 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 29 Jul 2020. 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 Saudi Arabia. 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?
Intraocular pressure (time frame: 36 months). The study lists 2 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 29 Jul 2020.