Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients

NCT06712758 | Recruiting

• 1 other identifier: Quatera
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Glaucoma

Keywords

intra ocular pressure; cataract; Quatera; glaucoma

Outcome Measures

Primary Outcomes (1)

• Complication rate during cataract surgery

  Complication rate during cataract surgery

  Month 1

Secondary Outcomes (4)

• Best corrected visual acuity

  Month 1

• Intraocular pressure

  1 month

• Retinal nerve fiber layer thickness

  1 year

• Visual field mean deviation

  Month 1

Study Arms (1)

Glaucoma patients in need of cataract surgery

Cataract surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Dr. Koen Willekens at Visionair Oogzorg.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Visionair Oogzorg: lead

Study Sites (1)

Visionair Oogzorg

Geel, 2400, Belgium

RECRUITING

MeSH Terms

Conditions

Cataract; Glaucoma

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Ocular Hypertension

Study Officials

• Koen Willekens

  Visionair Oogzorg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Willekens, Prof

CONTACT

003214808311; kw@visionairoogzorg.be

Sien Boons

CONTACT

003216715634; sb@visionairoogzorg.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: November 12, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

BE (1)