Clinical trial NCT05430295: Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens
Official title: Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lenses, Intraocular
Keywords: intraocular lens
intermediate vision
contrast sensitivity
monofocal
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective comparative interventional clinical study,
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.

Detailed description: Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens.

Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients aged 50-75 years old undergoing cataract surgery.
* Preoperative corneal astigmatism equal to or less than - 1.00 D.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Visual potential of less than 0.63 due to ocular pathologies.
* Corneal astigmatism over -1.00 D cylinder.
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).
* Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.
* Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.

Primary outcomes:
measure: Uncorrected and best-corrected distance, and intermediate visual acuity.
timeFrame: 3 months post operative
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 3 months post operative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasraliany Hospital
Study officials:
affiliation: Cairo University
name: yehia Salaheldin, PhD
role: STUDY_DIRECTOR
References: