Implantable Intraocular Pressure Sensor for Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1

NCT03421548 | Withdrawn

• 1 other identifier: 2016-6261
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and performance of the EYEMATE system in patients undergoing concomitant implantation of a BKPro type 1 and an EYEMATE sensor over the 24 months period beginning at implantation.

Conditions

Glaucoma; Blindness, Acquired; Keratitis, Herpetic; Ocular Cicatricial Pemphigoid; Corneal Injuries; Corneal Disease; Corneal Opacity

Outcome Measures

Primary Outcomes (1)

• IOP data gathering

  • To collect IOP data with the PRO-IOP system and evaluate the performance of the PRO-IOP system in the first 24 months following implantation. This will be compared to digital palpation and tonopen.

  24 months

Secondary Outcomes (2)

• Relationship between IOP data and determinants factors of glaucoma

  24 months

• Safety and tolerability of the EyeMate sensor

  24 months

Study Arms (2)

BKpro I with EyeMate

EXPERIMENTAL

Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularised cornea AND either a verifiable history of two or more prior failed corneal transplant procedures, limbal stem cells deficiency or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. Potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation.

Device: EyeMate

BKpro I

NO INTERVENTION

Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularised cornea AND either a verifiable history of two or more prior failed corneal transplant procedures, limbal stem cells deficiency or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. Potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation.

Interventions

EyeMate DEVICE

Patients will undergo implantation BKPro with concomitant implantation of the EyeMate pressure sensor. The surgical approach will involve a trephination of the central recipient cornea of adequate size. In subjects with adequate capsular support, the sensor device will be placed in the sulcus space by grasping the sensor's silicone sleeve at approximately the 3 and 9 o'clock positions and sliding it into the sulcus space. In subjects in whom capsular support is inadequate, the Eyemate implant will be sutured to the sclera. This is performed by placing an 8-O Gortex suture or 9-O prolene on CIF-4 needles around the antenna at the 2 and 7 o'clock positions and suturing the device to the sclera using an ab-interno technique.

BKpro I with EyeMate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularised cornea AND either a verifiable history of two or more prior failed corneal transplant procedures, limbal stem cells deficiency or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely.
• Ability and willingness to attend all scheduled visits and comply with all study procedures.

You may not qualify if:

• Reasonable chance of success with traditional keratoplasty.
• Current retinal detachment
• Connective tissue diseases
• History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to PRO-IOP implantation
• History of ocular or periocular malignancy
• Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device)
• Presence of another active medical eye implant and/or other active medical implants in the head/neck region
• Signs of current infection, including fever and current treatment with antibiotics
• Severe generalized disease that results in a life expectancy shorter than a year
• Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
• Currently pregnant or breastfeeding
• Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
• Intraoperative complication that would preclude implantation of the study device
• Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
• Previous or concurrent enrollment of the contralateral eye in this clinical study.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Implandata Ophthalmic Products GmbH: collaborator

MeSH Terms

Conditions

Glaucoma; Blindness; Keratitis, Herpetic; Pemphigoid, Benign Mucous Membrane; Corneal Injuries; Corneal Diseases; Corneal Opacity

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Conjunctival Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Mona Harissi-Dagher, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: February 5, 2018
• Study Start: November 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 5, 2018

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share