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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

Must not have

Aged less than 18 or more than 80 years old

Inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either younger than 18 or older than 80.

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I am unable to understand and agree to the study's details.

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I have had more than one vitrectomy surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of glaucoma development

Rate of retinal detachment

Rate of retroprosthetic membrane formation

Secondary study objectives

Change of visual acuity

Proportion of participants requiring glaucoma surgery

Proportion of patients with thinning of the nerve fiber layer

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met