Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients

Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients. Prospective, Investigator Initiated and Observational Case Series

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Cataract

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Koen Willekens, Prof; Phone Number: 003214808311; Email: kw@visionairoogzorg.be
• Study Contact Backup: Name: Sien Boons; Phone Number: 003216715634; Email: sb@visionairoogzorg.be

Study Locations

• Belgium
  • Geel, Belgium, 2400
    • Recruiting
    • Visionair Oogzorg
    • Contact: Sien Boons; Phone Number: +3214808311; Email: sb@visionairoogzorg.be
    • Contact: Koen Willekens, Prof. Dr.; Phone Number: +3214808311; Email: kw@visionairoogzorg.be
    • Principal Investigator: Koen Willekens, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from Dr. Koen Willekens at Visionair Oogzorg.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Glaucoma patients in need of cataract surgery; Cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate during cataract surgery	Complication rate during cataract surgery	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Best corrected visual acuity will be determined and recorded at the preoperative, day 1, week 1 and month 1 visit.	Month 1
Intraocular pressure	The intraocular pressure will be measured at the preoperative, day 1, week 1 and month 1 visit. Ocular hypertension will reported.	1 month
Retinal nerve fiber layer thickness	Optical Coherence Tomography will be performed at the preoperative and month 1 visit. Any abnormalities will be described.	1 year
Visual field mean deviation	The visual field examination will be performed at the preoperative and month 1 visit. Any abnormalities will be described.	Month 1

Collaborators and Investigators

• Sponsor: Visionair Oogzorg
• Investigators: Principal Investigator: Koen Willekens, Visionair Oogzorg

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cataract; glaucoma; intra ocular pressure; Quatera
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma; Ocular Hypotension
• Other Study ID Numbers: Quatera

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No