Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation

NCT05392738 | Unknown FDA Device

• 1 other identifier: 22/265-O_P
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

New extended depth of focus intraocular lenses (IOLs) are being used in a broader spectrum of patients than trifocal IOLs. The purpose of this study is to evaluate visual improvement after cataract surgery in patients with glaucoma or ocular hypertension undergoing simultaneous cataract surgery with i-Stent implantation with the implantation of a Vivity IOL. Results will be compared with a group of glaucoma or ocular hypertension undergoing isolated cataract surgery with Vivity implantation, as well as with patients with no pathology undergoing cataract surgery and Vivity implantation

Conditions

Lenses, Intraocular; Glaucoma Filtration Implants

Outcome Measures

Primary Outcomes (3)

• Binocular uncorrected distance visual acuity

  Binocular uncorrected distance visual acuity

  Three months after surgery

• Binocular uncorrected intermediate visual acuity

  Binocular uncorrected intermediate visual acuity

  Three months after surgery

• Binocular uncorrected near visual acuity

  Binocular uncorrected near visual acuity

  Three months after surgery

Secondary Outcomes (6)

• Binocular uncorrected distance visual acuity

  One month after surgery

• Binocular uncorrected intermediate visual acuity

  One month after surgery

• Binocular uncorrected near visual acuity

  One month after surgery

• Contrast sensitivity

  Three months after surgery

• Need for spectacle correction

  Three months after surgery

Study Arms (3)

Vivity with i-Stent

Patients with Glaucoma or Ocular Hypertension undergoing simultaneous cataract and i-Stent implantation, with Vivity intraocular lens

Device: I-Stent implantation

Glaucoma with Vivity

Patients with Glaucoma or Ocular Hypertension undergoing isolated phacoemulsification with Vivity intraocular lens

Healthy with Vivity

Patients with undergoing isolated phacoemulsification with Vivity intraocular lens

Interventions

I-Stent implantation DEVICE

I-Stent implantation

Vivity with i-Stent

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with glaucoma or ocular hypertension or healthy subjects undergoing bilateral cataract surgery with Vivity intraocular lens implantation with or without i-Stent implantation

Sponsors & Collaborators

• Clínica Rementería: lead

Study Sites (1)

Clínica Rementería

Madrid, 28010, Spain

Location

Study Officials

• Beatriz Puerto, MD

  Clínica Rementería

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: June 20, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

ES (1)