CClinicalTrials.gg
CompletedNCT05430295Updated Sep 27, 2022

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

An interventional study of phacoemulsification and monofocal intraocular lens implantation in Lenses, Intraocular, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was Aug 2021, 5 years 2 months ago, and no results have been posted to the registry.
  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lenses, Intraocular

Keywords

  • intraocular lens
  • intermediate vision
  • contrast sensitivity
  • monofocal
03

In context

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Eyhance intraocular lens

    10 patients bilaterally implanted with Eyhance intraocular lens

    Procedure: phacoemulsification · Procedure: monofocal intraocular lens implantation

  • Active comparator
    Tecnis 1 piece intraocular lens

    10 patients bilaterally implanted with Tecnis 1 piece intraocular lens

    Procedure: phacoemulsification · Procedure: monofocal intraocular lens implantation

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

    Also known as: cataract extraction

  • Proceduremonofocal intraocular lens implantation

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

06

What researchers measure

Primary outcomes

  1. Uncorrected and best-corrected distance, and intermediate visual acuity.

    Distance 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.

    Time frame: 3 months post operative

Secondary outcomes

  1. Contrast sensitivity

    Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m

    Time frame: 3 months post operative

07

Study locations

1 site
  • Kasraliany Hospital
    Giza, 11555, Egypt
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 2, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — the data of the patients are kept in files with the principal investigator

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05430295
Lead sponsor
Kasr El Aini Hospital
Responsible party
Rokaya Emad Radwan (ophthalmology resident, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 24, 2022
Start date
Jan 1, 2021
Primary completion
Aug 1, 2021
Completion
Nov 1, 2021
Last update
Sep 27, 2022

Study contacts

yehia Salaheldin, PhD
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion