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

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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

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

Condition or disease Intervention/treatment
Lenses, Intraocular Glaucoma Filtration Implants Device: I-Stent 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

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
Actual Study Start Date : June 20, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Group/Cohort Intervention/treatment
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
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



Primary Outcome Measures :
  1. Binocular uncorrected distance visual acuity [ Time Frame: Three months after surgery ]
    Binocular uncorrected distance visual acuity

  2. Binocular uncorrected intermediate visual acuity [ Time Frame: Three months after surgery ]
    Binocular uncorrected intermediate visual acuity

  3. Binocular uncorrected near visual acuity [ Time Frame: Three months after surgery ]
    Binocular uncorrected near visual acuity


Secondary Outcome Measures :
  1. Binocular uncorrected distance visual acuity [ Time Frame: One month after surgery ]
    Binocular uncorrected distance visual acuity

  2. Binocular uncorrected intermediate visual acuity [ Time Frame: One month after surgery ]
    Binocular uncorrected intermediate visual acuity

  3. Binocular uncorrected near visual acuity [ Time Frame: One month after surgery ]
    Binocular uncorrected near visual acuity

  4. Contrast sensitivity [ Time Frame: Three months after surgery ]
    Contrast sensitivity

  5. Need for spectacle correction [ Time Frame: Three months after surgery ]
    Need for spectacle correction

  6. Patient satisfaction [ Time Frame: Three months after surgery ]
    Patient satisfaction evaluated with the Catquest SF9 questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Exclusion Criteria: Ocular disease other than glaucoma


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05392738


Locations
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Spain
Clínica Rementería
Madrid, Spain, 28010
Sponsors and Collaborators
Clínica Rementería
Investigators
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Principal Investigator: Beatriz Puerto, MD Clínica Rementería
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Responsible Party: Clínica Rementería
ClinicalTrials.gov Identifier: NCT05392738    
Other Study ID Numbers: 22/265-O_P
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases