Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cataract, Glaucoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients. Prospective, Investigator Initiated and Observational Case Series
Overview
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.
Primary outcome measures
- Complication rate during cataract surgery [Time frame: Month 1]
Secondary outcome measures (4)
- Best corrected visual acuity [Time frame: Month 1]
- Intraocular pressure [Time frame: 1 month]
- Retinal nerve fiber layer thickness [Time frame: 1 year]
- Visual field mean deviation [Time frame: Month 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- Visionair Oogzorg — Geel
Identifiers
NCT: NCT06712758 · Quatera