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OpenTrials
Completed

NCT Number: NCT05430295

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

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.

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasraliany Hospital

Giza, 11555, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phacoemulsification

Procedure

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

Other names: cataract extraction

monofocal intraocular lens implantation

Procedure

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

Primary outcomes

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

    Time frame: 3 months post operative

    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.

Secondary outcomes

  1. Contrast sensitivity

    Time frame: 3 months post operative

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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