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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Lenses, Intraocular, Glaucoma Filtration Implants

Intervention / Treatment
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* Device: I-Stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral cataract surgery with Vivity implantation with or without i_STent implantation Exclusion Criteria: Ocular disease other than glaucoma

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vivity with i-Stent<br>Patients with Glaucoma or Ocular Hypertension undergoing simultaneous cataract and i-Stent implantation, with Vivity intraocular lens | Device: I-Stent implantation<br>* I-Stent implantation<br>|
| Glaucoma with Vivity<br>Patients with Glaucoma or Ocular Hypertension undergoing isolated phacoemulsification with Vivity intraocular lens | |
| Healthy with Vivity<br>Patients with undergoing isolated phacoemulsification with Vivity intraocular lens | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular uncorrected distance visual acuity | Binocular uncorrected distance visual acuity | One month after surgery | 
| Binocular uncorrected intermediate visual acuity | Binocular uncorrected intermediate visual acuity | One month after surgery | 
| Binocular uncorrected near visual acuity | Binocular uncorrected near visual acuity | One month after surgery | 
| Contrast sensitivity | Contrast sensitivity | Three months after surgery | 
| Need for spectacle correction | Need for spectacle correction | Three months after surgery | 
| Patient satisfaction | Patient satisfaction evaluated with the Catquest SF9 questionnaire | Three months after surgery |