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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05392738
Enrollment
45
Registered
2022-05-26
Start date
2022-06-20
Completion date
2024-06-30
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Filtration Implants, Lenses, Intraocular

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

Interventions

DEVICEI-Stent implantation

I-Stent implantation

Sponsors

Clínica Rementería
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

Bilateral cataract surgery with Vivity implantation with or without i\_STent implantation

Exclusion criteria

Ocular disease other than glaucoma

Design outcomes

Primary

MeasureTime frameDescription
Binocular uncorrected distance visual acuityThree months after surgeryBinocular uncorrected distance visual acuity
Binocular uncorrected intermediate visual acuityThree months after surgeryBinocular uncorrected intermediate visual acuity
Binocular uncorrected near visual acuityThree months after surgeryBinocular uncorrected near visual acuity

Secondary

MeasureTime frameDescription
Binocular uncorrected intermediate visual acuityOne month after surgeryBinocular uncorrected intermediate visual acuity
Binocular uncorrected near visual acuityOne month after surgeryBinocular uncorrected near visual acuity
Patient satisfactionThree months after surgeryPatient satisfaction evaluated with the Catquest SF9 questionnaire
Need for spectacle correctionThree months after surgeryNeed for spectacle correction
Contrast sensitivityThree months after surgeryContrast sensitivity
Binocular uncorrected distance visual acuityOne month after surgeryBinocular uncorrected distance visual acuity

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026