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

K

Kasr El Aini Hospital

Status

Completed

Conditions

Lenses, Intraocular

Treatments

Procedure: monofocal intraocular lens implantation
Procedure: phacoemulsification

Study type

Interventional

Funder types

Other

Identifiers

NCT05430295
MS-239-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Eyhance intraocular lens
Active Comparator group
Description:
10 patients bilaterally implanted with Eyhance intraocular lens
Treatment:
Procedure: phacoemulsification
Procedure: monofocal intraocular lens implantation
Tecnis 1 piece intraocular lens
Active Comparator group
Description:
10 patients bilaterally implanted with Tecnis 1 piece intraocular lens
Treatment:
Procedure: phacoemulsification
Procedure: monofocal intraocular lens implantation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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