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Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients

NCT ID: NCT06712758

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-12

Study Completion Date

2025-12-31

Brief Summary

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You were selected to participate in this observational study because you suffer from glaucoma and cataracts. For the cataract you will have cataract surgery. This study will not affect your treatment, it will only collect data on what is performed before, during and after the procedure.

The aim of this data collection is to demonstrate the safety of a new generation of cataract surgical devices in patients who also suffer from glaucoma. They are glaucoma patients who have an increased sensitivity to eye pressure increases both during and after surgery. The new surgical device makes it possible to safely perform cataract surgery under low pressures. This could, at least theoretically, provide an advantage for patients who also suffer from glaucoma.

Detailed Description

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Cataract surgery is a highly standardized procedure. However a new phacoemulsification system "Quatera 700" has been developed by Carl Zeiss Meditec. The system has a unique patented QUATTRO Pump that directly controls infusion and aspiration and enables a synchronous change in both. It has four membranes, which directly regulate infusion and aspiration and maintain a pre-set intraocular pressure (IOP), resulting in a stable anterior chamber during the surgery. The membranes are activated by pneumatic pressure regulated by sensors that measure infusion and aspiration flows which allows the system to determine and compensate for incisional leakage as well. This innovative pump system allows surgeons to significantly decrease the intra-ocular pressure during cataract surgery. In respect to competitive devices on the market, the Quatera system is able to operate with pressure four times lower than average. Especially in glaucoma patients (patients suffering from optic nerve head damage due to elevated intraocular pressures), performing surgery with lower intra-ocular pressures would help in avoiding extra nerve fiber layer damage and overall safety of the surgery.

Conditions

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Cataract Glaucoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Glaucoma patients in need of cataract surgery

Cataract surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with glaucoma that are diagnosed with age-related cataract

Exclusion Criteria

* Unwilling to sign informed consent
* Functionally monophtalmic patient
* Endothelial dystrophy
* Active uveitis
* Known corticosteroid responder
* Presence of uncontrolled systemic disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visionair Oogzorg

OTHER

Sponsor Role lead

Responsible Party

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Koen Willekens

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koen Willekens

Role: PRINCIPAL_INVESTIGATOR

Visionair Oogzorg

Locations

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Visionair Oogzorg

Geel, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Koen Willekens, Prof

Role: CONTACT

[email protected]
003214808311

Sien Boons

Role: CONTACT

[email protected]
003216715634

Facility Contacts

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Sien Boons

Role: primary

[email protected]
+3214808311

Koen Willekens, Prof. Dr.

Role: backup

[email protected]
+3214808311

Other Identifiers

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Quatera

Identifier Type: -

Identifier Source: org_study_id