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GDD Timing with Boston KPro for Glaucoma (GDD-KPro Trial)

N/A

Recruiting

Led By Mona Harissi-Dagher, MD, FRCSC

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Physical condition suitable for undergoing surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline ddls on optic nerve photographs at 12 months

Awards & highlights

GDD-KPro Trial Summary

This trial will help surgeons to determine whether it is better to implant a glaucoma drainage device (GDD) at the time of the Boston KPro surgery or 6 months later, in the prevention of the progression of glaucoma.

Who is the study for?

This trial is for adults over 18 who've had a failed corneal transplant and have poor vision (20/80 or worse) in the affected eye. They should be physically fit for surgery but not have end-stage glaucoma or terminal retinal diseases.Check my eligibility

What is being tested?

The study tests if getting a Glaucoma Drainage Device (GDD) at the same time as Boston Keratoprosthesis (KPro) surgery is better than waiting 6 months. The goal is to see which timing best prevents glaucoma progression and maintains vision.See study design

What are the potential side effects?

Potential side effects may include complications related to KPro such as further vision loss, infection, or issues with the GDD like discomfort or improper drainage of eye fluid.

GDD-KPro Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fit for surgery.

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I need a corneal transplant because my cornea is not clear.

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I have had a corneal transplant that did not succeed.

GDD-KPro Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline visual field mean deviation at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline visual field mean deviation at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline visual field mean deviation at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual field mean deviation

Secondary outcome measures

Change of visual acuity

Disc Damage Likelihood Scale (DDLS) on clinical examination

Disc Damage Likelihood Scale (DDLS) on stereoscopic photographs of the optic nerve

+1 more

GDD-KPro Trial Design

2Treatment groups

Active Control

Group I: Simultaneous implantationActive Control2 Interventions

Simultaneous implantation of a glaucoma drainage device at the time of Boston keratoprosthesis type 1 surgery

Group II: Implantation at post-Kpro at 6 monthsActive Control2 Interventions

Implantation of a glaucoma drainage device 6 months after Boston keratoprosthesis type 1 surgery

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,597 Total Patients Enrolled

7 Trials studying Glaucoma

430 Patients Enrolled for Glaucoma

Mona Harissi-Dagher, MD, FRCSCPrincipal InvestigatorDepartment of Ophthalmology, Centre Hospitalier de l'Université de Montréal

Media Library

Boston keratoprosthesis type 1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02084745 — N/A

Glaucoma Research Study Groups: Simultaneous implantation, Implantation at post-Kpro at 6 months

Glaucoma Clinical Trial 2023: Boston keratoprosthesis type 1 Highlights & Side Effects. Trial Name: NCT02084745 — N/A

Boston keratoprosthesis type 1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02084745 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still accepting volunteers for this experiment?

"Clinicaltrials.gov attests that this medical trial, first unveiled on May 26th 2014 and recently updated November 16th 2022, is actively enrolling participants."

Answered by AI

How many participants are being enrolled in this experiment?

"Affirmative. Clinicaltrials.gov data denotes that this clinical trial, which initially went public on May 26th 2014, is currently recruiting individuals to participate. A total of 40 patients are required from a single location."

Answered by AI

Recent research and studies

CorneaJournal

Boston Keratoprosthesis Outcomes and Complications

Chew, Hall F, Brandon D Ayres, Kristin M Hammersmith, Christopher J Rapuano, Peter R Laibson, Jonathan S Myers, Ya-Ping Jin, and Elisabeth J Cohen. 2009. “Boston Keratoprosthesis Outcomes and Complications”. Cornea. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ico.0b013e3181a186dc.

Current Opinion in OphthalmologyJournal

Evaluation and Management of Glaucoma After Keratoprosthesis

Banitt, Michael. 2011. “Evaluation and Management of Glaucoma After Keratoprosthesis”. Current Opinion in Ophthalmology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/icu.0b013e328343723d.

OphthalmologyJournal

The Boston Type I Keratoprosthesis

Aldave, Anthony J., Khairidzan M. Kamal, Rosalind C. Vo, and Fei Yu. 2009. “The Boston Type I Keratoprosthesis”. Ophthalmology. Elsevier BV. doi:10.1016/j.ophtha.2008.12.058.

American Journal of OphthalmologyJournal