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

Lenses, Intraocular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05392738
• Other study ID #: 22/265-O_P
• Status: Enrolling by invitation
• Start date: June 20, 2022
• Est. completion date: June 2024

Study information

• Verified date: July 2022
• Source: Clínica Rementería
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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

Exclusion Criteria: Ocular disease other than glaucoma

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Lenses, Intraocular

Intervention

Device:
• I-Stent implantation
I-Stent implantation

Locations

Country	Name	City	State
Spain	Clínica Rementería	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Clínica Rementería

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular uncorrected distance visual acuity	Binocular uncorrected distance visual acuity	Three months after surgery
Primary	Binocular uncorrected intermediate visual acuity	Binocular uncorrected intermediate visual acuity	Three months after surgery
Primary	Binocular uncorrected near visual acuity	Binocular uncorrected near visual acuity	Three months after surgery
Secondary	Binocular uncorrected distance visual acuity	Binocular uncorrected distance visual acuity	One month after surgery
Secondary	Binocular uncorrected intermediate visual acuity	Binocular uncorrected intermediate visual acuity	One month after surgery
Secondary	Binocular uncorrected near visual acuity	Binocular uncorrected near visual acuity	One month after surgery
Secondary	Contrast sensitivity	Contrast sensitivity	Three months after surgery
Secondary	Need for spectacle correction	Need for spectacle correction	Three months after surgery
Secondary	Patient satisfaction	Patient satisfaction evaluated with the Catquest SF9 questionnaire	Three months after surgery