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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05392738
Recruitment Status : Enrolling by invitation
First Posted : May 26, 2022
Last Update Posted : July 20, 2022
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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