Efficacy and Safety of ab Interno Trabeculectomy With the Kahook Dual Blade

NCT04202562 | Completed DMC

• 1 other identifier: 16/560_P
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The Kahook Dual Blade is a single-use device specially designed to create a clean cut in the trabecular meshwork. This ablation in the trabecular meshwork allows a better outflow of the aqueous humor, thus reducing the intraocular pressure (IOP), theoretically beyond the IOP reduction achieved by other minimally invasive glaucoma surgery (MIGS) devices. Studies already published showed good results in terms of the reduction of the number of glaucoma medications and the reduction in the IOP, but not a single study has been performed prospectively comparing the efficacy of the technique, not even with the cataract surgery.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Hypertension; Intraocular Pressure; Cataract

Keywords

Glaucoma; Ocular hypertension; Glaucoma, Open-Angle; Ab interno trabeculectomy; Phacoemulsification; Combined surgery; Minimally Invasive Glaucoma Surgery

Outcome Measures

Primary Outcomes (2)

• Evolution during follow up of the intraocular pressure

  in mmHg

  Up to 12 months

• Reduction in number of glaucoma medications

  Difference between number of glaucoma medications before and after the treatment

  Up to 12 months

Secondary Outcomes (5)

• Increase in visual acuity

  Up to 12 months

• Rate of reduction in endothelial cell count

  Up to 12 months

• Increase of corneal astigmatism

  Up to 12 months

• Rate of visual field progression

  Up to 12 months

• Proportion of patients achieving the success endpoint

  Up to 12 months

Study Arms (2)

Combined surgery

EXPERIMENTAL

Participants intervened of combined ab interno trabeculectomy and cataract surgery at the same time

Procedure: Ab interno trabeculectomy; Procedure: Cataract

Cataract surgery

ACTIVE COMPARATOR

Participants intervened of cataract surgery alone

Procedure: Cataract

Interventions

Ab interno trabeculectomy PROCEDURE

Ab interno trabeculectomy performed after pupil contraction and 90 degrees ablation of the nasal trabecular meshwork

Combined surgery

Cataract PROCEDURE

Cataract surgery with minimal clear cornea incision and phacoemulsification

Cataract surgery; Combined surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 - 85 years
• Full comprehension and signing of the informed consent
• Preoperative intraocular pressure below 24 mmHg and at least one glaucoma medication
• Previous diagnose of open-angle glaucoma or ocular hypertension, including pseudoexfoliative glaucoma or pigment dispersion syndrome
• Mild to moderate glaucoma, according to the Hodapp-Parrish-Anderson classification

You may not qualify if:

• Not signing of the informed consent
• Not being able to attend to all the follow-up visits
• Young females during pregnancy or lactation
• Any other form of glaucoma not previously mentioned
• Glaucoma secondary to elevated episcleral venous pressure
• Preoperative best-corrected visual acuity lower than 0.1
• Clear lens extraction
• Severe or end-stage glaucoma
• Previous glaucoma surgery, cataract surgery or retinal surgery
• Patients taking anticoagulant medication that could not be discontinued during the perioperative period
• Oral anhydrase carbonic inhibitors
• Severe or uncontrolled systemic disease

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital San Carlos

Madrid, 28040, Spain

Location

Related Publications (3)

• Greenwood MD, Seibold LK, Radcliffe NM, Dorairaj SK, Aref AA, Roman JJ, Lazcano-Gomez GS, Darlington JK, Abdullah S, Jasek MC, Bahjri KA, Berdahl JP. Goniotomy with a single-use dual blade: Short-term results. J Cataract Refract Surg. 2017 Sep;43(9):1197-1201. doi: 10.1016/j.jcrs.2017.06.046.

  PMID: 28991617 BACKGROUND

• Dorairaj SK, Seibold LK, Radcliffe NM, Aref AA, Jimenez-Roman J, Lazcano-Gomez GS, Darlington JK, Mansouri K, Berdahl JP. 12-Month Outcomes of Goniotomy Performed Using the Kahook Dual Blade Combined with Cataract Surgery in Eyes with Medically Treated Glaucoma. Adv Ther. 2018 Sep;35(9):1460-1469. doi: 10.1007/s12325-018-0755-4. Epub 2018 Aug 4.

  PMID: 30078175 BACKGROUND

• Ventura-Abreu N, Garcia-Feijoo J, Pazos M, Biarnes M, Morales-Fernandez L, Martinez-de-la-Casa JM. Twelve-month results of ab interno trabeculectomy with Kahook Dual Blade: an interventional, randomized, controlled clinical study. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2771-2781. doi: 10.1007/s00417-021-05213-0. Epub 2021 Apr 27.

  PMID: 33907888 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Hypertension; Cataract; Glaucoma

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Julian Garcia Feijoo, Professor

  Hospital San Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: One group received combined surgery, while the other cataract surgery alone

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 17, 2019
• Study Start: February 2, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 30, 2018
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)