Visual Performance Following Implantation of Presbyopia Correcting IOLs

Visual Impairment Clinical Trial

Official title:

Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907955
• Other study ID #: 02282021065727
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2021
• Source: Dar Al Shifa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Loss of Visual Contrast Sensitivity
• Near Vision
• Presbyopia
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Procedure:
• phacoemulsification with implantation of presbyopia correcting IOL
cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL

Locations

Country	Name	City	State
Kuwait	Daralshifa hospital	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Dar Al Shifa Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	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.	6 months postoperatively.
Secondary	defocus curve	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.	6 months postoperatively.
Secondary	contract senstivity	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.	6 months postoperatively.
Secondary	photic phenomena	The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother.	6 months postoperatively.
Secondary	spectacle independence	patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.	6 months postoperatively.