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

• ClinicalTrials.gov Identifier: NCT05392738
• Recruitment Status: Enrolling by invitation
• First Posted: May 26, 2022
• Last Update Posted: July 20, 2022
• Sponsor: Clínica Rementería
• Information provided by (Responsible Party): Clínica Rementería

Tracking Information

• First Submitted Date: May 23, 2022
• First Posted Date: May 26, 2022
• Last Update Posted Date: July 20, 2022
• Actual Study Start Date: June 20, 2022
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 23, 2022)

• Binocular uncorrected distance visual acuity [ Time Frame: Three months after surgery ]
  Binocular uncorrected distance visual acuity
• Binocular uncorrected intermediate visual acuity [ Time Frame: Three months after surgery ]
  Binocular uncorrected intermediate visual acuity
• Binocular uncorrected near visual acuity [ Time Frame: Three months after surgery ]
  Binocular uncorrected near visual acuity

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 23, 2022)

• Binocular uncorrected distance visual acuity [ Time Frame: One month after surgery ]
  Binocular uncorrected distance visual acuity
• Binocular uncorrected intermediate visual acuity [ Time Frame: One month after surgery ]
  Binocular uncorrected intermediate visual acuity
• Binocular uncorrected near visual acuity [ Time Frame: One month after surgery ]
  Binocular uncorrected near visual acuity
• Contrast sensitivity [ Time Frame: Three months after surgery ]
  Contrast sensitivity
• Need for spectacle correction [ Time Frame: Three months after surgery ]
  Need for spectacle correction
• Patient satisfaction [ Time Frame: Three months after surgery ]
  Patient satisfaction evaluated with the Catquest SF9 questionnaire

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
• Official Title: Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
• 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

Detailed Description

The purpose of this study is to report in detail visual function and patient satisfaction, as well as the need for spectacle correction, in patients with glaucoma and ocular hypertension undergoing cataract surgery with bilateral implantation of an extended depth of focus IOL, the Vivity IOL. The study also seeks to determine if there are differences in the speed of visual improvement between patients undergoing isolated cataract surgery and patients undergoing simultaneous i-Stent implantation. Results will also be compared with a group of patients with no ocular pathology undergoing cataract surgery with Vivity implantation.

Patients will be asked to join the study once the type of surgery (isolated phacoemulsification versus phacoemulsification combined with i-Stent implantation) and the type of lens to be implanted (monofocal, EDoF, trifocal) has been agreed between ophthalmologist and patient. Therefore, inclusion in the study will have no influence on surgical indication.

Once informed consent has been signed, the patient will be included in the study.

Explorations specific for the study will be performed 3 and 12 months after surgery and include:

Defocus curves Contrast sensitivity Self-reported photic phenomena Need for spectacle correction Satisfaction measured with the Catquest SF9 questionnaire

Besides study-specific procedures, the following explorations which are standard of care will be performed one day, one week and one month after surgery:

Uncorrected binocular visual acuity for distance, intermediate and near distances Monocular distance corrected and uncorrected visual acuity Residual subjective refraction Slit-lamp examination Intraocular pressure and number of hypotensive drugs required Description of any intra- or postsurgical complications

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

• Lenses, Intraocular
• Glaucoma Filtration Implants

Intervention

Device: I-Stent implantation

I-Stent implantation

Study Groups/Cohorts

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: May 23, 2022): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria: Bilateral cataract surgery with Vivity implantation with or without i_STent implantation

Exclusion Criteria: Ocular disease other than glaucoma

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 95 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05392738
• Other Study ID Numbers: 22/265-O_P
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Clínica Rementería
• Original Responsible Party: Same as current
• Current Study Sponsor: Clínica Rementería
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Beatriz Puerto, MD; Clínica Rementería

• PRS Account: Clínica Rementería
• Verification Date: July 2022