Corneal Endothelial Cell Loss After Trabeculectomy Versus Phakotrabeculectomy

NCT03107000 | Completed

• 1 other identifier: 2915-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Corneal endothelial cells health and pumping function is crucial to permit corneal optical clarity by keeping cornea in relatively dehydrated state. Corneal endothelial damage has been associated with most types of intraocular surgery. Trabeculectomy is the standard glaucoma surgical intervention in management of progressive glaucoma despite of medical therapy which can be performed in combination with Cataract surgery (Phacoemulsification and IOL implantation) in patients with cataract-impaired visual acuity. In this study, the investigators will investigate and compare the corneal endothelial cells number and health status before and after trabeculectomy vs. combined surgery (at 1 month and 3 months post-op visits) using Specular microscopy which is a non-invasive technique to access the structure and function of the corneal endothelium by permitting visualization of the corneal endothelial mosaic to assess the effect of this surgical intervention on corneal endothelial cells health and number.

Conditions

Corneal Endothelial Cell Loss; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Endothelial cell count

  Specular microscopy

  3 months post surgery

Secondary Outcomes (4)

• IOP

  3 month visit

• Visual acuity

  3 month visit

• Endothelial cell morphology - qualitative

  3 month visit

• Central corneal thickness

  3 month visit

Study Arms (2)

Trabeculectomy group

ACTIVE COMPARATOR

Patients with Open Angle Glaucoma requiring incisional surgery in whom specular microscopy can be performed without any delay in their treatment

Procedure: Trabeculectomy

Phako-trabeculectomy group

ACTIVE COMPARATOR

Patients with Open Angle Glaucoma and cataract requiring incisional surgery in whom specular microscopy can be performed without any delay in their treatment

Procedure: Phako-trabeculectomy

Interventions

Trabeculectomy PROCEDURE

Incisional surgery for glaucoma

Also known as: Trab

Trabeculectomy group

Phako-trabeculectomy PROCEDURE

Incisional surgery for glaucoma plus cataract

Also known as: Phako-trab

Phako-trabeculectomy group

Eligibility Criteria

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

You may qualify if:

• Age over 18 y/o.
• Patients with well established Open Angle Glaucoma including Primary open angle glaucoma, Pseudoexfoliation or Pigmentary Glaucoma \& Steroid induced Glaucoma requiring incisional surgery for Intraocular pressure higher than target, despite receiving maximal tolerable medical treatment or were intolerant to medications with progressive glaucoma related visual field defects or optic nerve changes.
• Any of a above who needs cataract surgery
• In those specular microscopy can be performed without any delay in their treatment.
• Decision makers able to give informed consent.

You may not qualify if:

• Unable to attend follow -up visits.
• Angle closure glaucoma.
• Secondary open angle glaucoma other than PXFG, PG or SIG.
• Previous intraocular surgery/laser procedures other than laser trabeculoplasty.
• Post operative complications (if any) including flat anterior chamber, endophthalmitis \& severe post op inflammation.
• Pre-op corneal disease

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss; Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Catherine Birt, MD

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel group comparison

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: April 11, 2017
• Study Start: September 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: October 14, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)