Visual Performance Following Implantation of Presbyopia Correcting IOLs

Not Applicable

Completed

• Conditions: Loss of Visual Contrast Sensitivity; Visual Impairment; Near Vision

• Registration Number: NCT04907955
• Lead Sponsor: Dar Al Shifa Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2021-05
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-06-01
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
visual acuity	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 Outcome Measures

Name	Time	Method
spectacle independence	6 months postoperatively.	patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.
defocus curve	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.
contract senstivity	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.
photic phenomena	6 months postoperatively.	The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother.

Trial Locations

Locations (1)

Daralshifa hospital; 🇰🇼 Kuwait, Kuwait