Effect of Intra-subject Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intraocular Pressure
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 4/3/2019 |
| Start Date: | March 6, 2019 |
| End Date: | January 31, 2023 |
| Contact: | Asher Weiner, MD |
| Email: | aweiner7@gmail.com |
| Phone: | 716-881-7900 |
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.
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.
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
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
Buffalo, New York 14209
Principal Investigator: Asher Weiner, MD
Phone: 716-881-7900
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