An interventional study of KDB/Phacoemulsification and Trabectome/Phacoemulsification in Glaucoma, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment
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.
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
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 80 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
Eyes needing glaucoma and cataract extraction will receive combined KDB and phacoemulsification in one eye of a patient
Procedure: KDB/Phacoemulsification
Contralateral eyes needing glaucoma and cataract extraction will receive combined Trabectome and phacoemulsification in contralateral eye of the same patient
Procedure: Trabectome/Phacoemulsification
50 eyes of 50 patients will receive combined KDB/phaco surgery
The contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery
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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo