Clinical trial NCT05392738: Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
Official title: Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lenses, Intraocular
Glaucoma Filtration Implants
Lead sponsor: Clínica Rementería
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Exclusion Criteria: Ocular disease other than glaucoma

Primary outcomes:
measure: Binocular uncorrected distance visual acuity
timeFrame: Three months after surgery
measure: Binocular uncorrected intermediate visual acuity
timeFrame: Three months after surgery
measure: Binocular uncorrected near visual acuity
timeFrame: Three months after surgery
Secondary outcomes:
measure: Binocular uncorrected distance visual acuity
timeFrame: One month after surgery
measure: Binocular uncorrected intermediate visual acuity
timeFrame: One month after surgery
measure: Binocular uncorrected near visual acuity
timeFrame: One month after surgery
measure: Contrast sensitivity
timeFrame: Three months after surgery
measure: Need for spectacle correction
timeFrame: Three months after surgery
measure: Patient satisfaction
timeFrame: Three months after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Rementería
Study officials:
affiliation: Clínica Rementería
name: Beatriz Puerto, MD
role: PRINCIPAL_INVESTIGATOR
References: