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Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens

Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05430295
Enrollment
20
Registered
2022-06-24
Start date
2021-01-01
Completion date
2021-11-01
Last updated
2022-09-27

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

Conditions

Lenses, Intraocular

Keywords

intraocular lens, intermediate vision, contrast sensitivity, monofocal

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.

Interventions

PROCEDUREphacoemulsification

cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients

implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is a prospective comparative interventional clinical study,

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Uncorrected and best-corrected distance, and intermediate visual acuity.3 months post operativeDistance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values.

Secondary

MeasureTime frameDescription
Contrast sensitivity3 months post operativeContrast sensitivity was measured using Pelli Robson illuminated chart at 1m

Countries

Egypt

Outcome results

None listed

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