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Completed

NCT Number: NCT04907955

Visual Performance Following Implantation of Presbyopia Correcting IOLs

The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.

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Key information

Conditions

Loss of Visual Contrast Sensitivity Eye Diseases Myopia Near Vision Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractive Errors Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daralshifa hospital

Kuwait City, Kuwait

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with normal ocular examination apart from cataract.

Exclusion criteria

  • previous ocular surgery.
  • ocular pathology or corneal abnormalities.
  • an endothelial cell count below 2000 cells/mm2.
  • corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).

Treatment and study plan

phacoemulsification with implantation of presbyopia correcting IOL

Procedure

cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL

Primary outcomes

  1. visual acuity

    Time frame: 6 months postoperatively.

    The monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuity (4 m), uncorrected intermediate visual acuity (UIVA) (60 cm and 80 cm), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (40 cm), and distance-corrected near visual acuity (DCNVA) were assessed. Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm.

Secondary outcomes

  1. defocus curve

    Time frame: 6 months postoperatively.

    The binocular defocus curve was done to evaluate the functional range of vision. The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps.

  2. contract senstivity

    Time frame: 6 months postoperatively.

    The CSV-1000 system (Vector Vision Inc. Greenville, OH, USA) was used to measure contrast sensitivity under photopic and mesopic conditions without glare with spatial frequencies ranging between 3 and 18 cycles/degree.

  3. photic phenomena

    Time frame: 6 months postoperatively.

    The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother.

  4. spectacle independence

    Time frame: 6 months postoperatively.

    patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.

Sponsors and collaborators

Lead sponsor

Dar Al Shifa Hospital

Other

Registry information

Official study title

Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2021
Registry last updated
Jun 1, 2021

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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