Clinical trial NCT06712758: Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients
Official title: Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients. Prospective, Investigator Initiated and Observational Case Series
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Glaucoma
Keywords: intra ocular pressure
cataract
Quatera
glaucoma
Lead sponsor: Visionair Oogzorg
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Dr. Koen Willekens at Visionair Oogzorg.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate during cataract surgery
timeFrame: Month 1
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: Month 1
measure: Intraocular pressure
timeFrame: 1 month
measure: Retinal nerve fiber layer thickness
timeFrame: 1 year
measure: Visual field mean deviation
timeFrame: Month 1
Other outcomes:
Locations:
city: Geel
country: Belgium
facility: Visionair Oogzorg
Study officials:
affiliation: Visionair Oogzorg
name: Koen Willekens
role: PRINCIPAL_INVESTIGATOR
References: