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

• Conditions: Lenses, Intraocular; Glaucoma Filtration Implants
• Interventions: Device: I-Stent implantation

• Registration Number: NCT05392738
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Study Start: 2022-06-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Bilateral cataract surgery with Vivity implantation with or without i_STent implantation

Exclusion Criteria

Ocular disease other than glaucoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Binocular uncorrected near visual acuity	Three months after surgery	Binocular uncorrected near visual acuity
Binocular uncorrected distance visual acuity	Three months after surgery	Binocular uncorrected distance visual acuity
Binocular uncorrected intermediate visual acuity	Three months after surgery	Binocular uncorrected intermediate visual acuity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clínica Rementería; 🇪🇸 Madrid, Spain