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Procedure

Endoscopic-Assisted Vitrectomy for Corneal Transplant Complications (KPro-HP-Endo Trial)

N/A
Recruiting
Led By Mona Harissi-Dagher, MD
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
Aged from 18 to 80 years old
Pars plana vitrectomy candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

KPro-HP-Endo Trial Summary

This trial is testing whether performing a complete vitrectomy at the same time as KPro surgery, assisted by endoscopy, reduces postoperative complications.

Who is the study for?
This trial is for adults aged 18 to 80 who are candidates for a corneal transplant using the Boston keratoprosthesis type 1 and also need vitrectomy surgery. Participants must be able to follow the study's procedures over time. It's not open to those under 18 or over 80, anyone unable to consent, or patients needing repeat surgeries of these types.Check my eligibility
What is being tested?
The study tests if peeling the anterior hyaloid membrane with endoscopic assistance during corneal transplant surgery can reduce complications like glaucoma and retinal detachment compared to doing this step after the transplant without endoscopy.See study design
What are the potential side effects?
Potential side effects may include issues related to eye surgery such as increased eye pressure, infection risk, inflammation, vision changes, or detachment of the retina.

KPro-HP-Endo Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am a candidate for eye surgery to remove the vitreous gel.

KPro-HP-Endo Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Rate of glaucoma development
Rate of retinal detachment
Rate of retroprosthetic membrane formation
Secondary outcome measures
Change of visual acuity
Proportion of participants requiring glaucoma surgery
Proportion of patients with thinning of the nerve fiber layer
+5 more

KPro-HP-Endo Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with KPro, PPV, and endoscopyExperimental Treatment1 Intervention
Patients will receive at the same time a Boston keratoprosthesis type 1 (KPro) with a pars plana vitrectomy (PPV) with anterior hyaloid membrane peeling assisted by endoscopy.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
129,289 Total Patients Enrolled
3 Trials studying Postoperative Complications
1,026 Patients Enrolled for Postoperative Complications
Mona Harissi-Dagher, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
3 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04337944 — N/A
Postoperative Complications Research Study Groups: Patients with KPro, PPV, and endoscopy
Postoperative Complications Clinical Trial 2023: Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy Highlights & Side Effects. Trial Name: NCT04337944 — N/A
Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04337944 — N/A

Frequently Asked Questions

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

Are individuals aged 55 and above eligible for this exploratory research?

"In order to adhere with the inclusion criteria, potential participants of this trial must be aged between 18 and 80. An additional 9 trials target people under 18 years old while 174 are suited for elderly individuals over 65."

Answered by AI

Are there any available slots for participation in this research project?

"According to clinicaltrials.gov, this research endeavour is currently accepting participants and has been since April 8th 2020; the trial was last updated on July 4th 2022."

Answered by AI

Is it possible to volunteer for this experiment?

"The research team is in search of 20 endoscopy patients that are between the ages 18 and 80. Eligible candidates must have had a pars plana vitrectomy, as well as be able to commit to full-scale monitoring throughout the duration of this trial."

Answered by AI

How many participants are being admitted to this evaluation?

"Affirmative, the clinicaltrial.gov website reveals that this medical trial is actively recruiting members of its study cohort. It was initially posted on April 8th 2020 and has been updated as recently as July 4th 2022; it requires 20 individuals to be recruited from a single site."

Answered by AI

What is the specific aim of this medical experiment?

"During the 12 month period, this trial seeks to evaluate Rate of retroprosthetic membrane formation and several secondary outcomes including Proportion of participants requiring glaucoma surgery (including glaucoma drainage device, trabeculectomy or cyclophotocoagulation), Proportion of patients with thinning of the nerve fiber layer based on Spectral Domain Optical Coherence Tomography (SD-OCT) results, and Proportion of patients yielding a visual acuity better than 20/200 as measured using Snellen chart."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
Centre Hospitalier de l'Université de Montréal (CHUM)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~2 spots leftby Oct 2024