Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06712758

Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cataract Eye Diseases Glaucoma Lens Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complication rate during cataract surgery

    Time frame: Month 1

    Complication rate during cataract surgery

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: Month 1

    Best corrected visual acuity will be determined and recorded at the preoperative, day 1, week

    1 and month 1 visit.

  2. Intraocular pressure

    Time frame: 1 month

    The intraocular pressure will be measured at the preoperative, day 1, week 1 and month 1 visit. Ocular hypertension will reported.

  3. Retinal nerve fiber layer thickness

    Time frame: 1 year

    Optical Coherence Tomography will be performed at the preoperative and month 1 visit. Any abnormalities will be described.

  4. Visual field mean deviation

    Time frame: Month 1

    The visual field examination will be performed at the preoperative and month 1 visit. Any abnormalities will be described.

Study contacts

Contact information is provided by the study sponsor or research team.

Koen Willekens, Prof

CONTACT

[email protected]

003214808311

Sien Boons

CONTACT

[email protected]

003216715634

Sponsors and collaborators

Lead sponsor

Visionair Oogzorg

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.