Visual Performance Following Implantation of Presbyopia Correcting IOLs

• Sponsor: Dar Al Shifa Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04907955
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Loss of Visual Contrast Sensitivity; Near Vision; Visual Impairment	Procedure: phacoemulsification with implantation of presbyopia correcting IOL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses
• Actual Study Start Date: Jun 1, 2019
• Actual Primary Completion Date: May 30, 2020
• Actual Study Completion Date: May 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: panoptix PANFOCAL intraocular lens panoptix PANFOCAL intraocular lensis a single-piece aspheric non-apodized diffractive panfocal IOL that distributes light energy to three focal points in both small and large pupil conditions	Procedure: phacoemulsification with implantation of presbyopia correcting IOL; cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
Active Comparator: Trifocal Diffractive the AT LISA intraocular lens Trifocal Diffractive the AT LISA is a preloaded single-piece aspheric diffractive trifocal IOL and made of hydrophilic acrylic with a hydrophobic surface with an ultraviolet absorber. This aspheric IOL is aberration -correcting in order to reduce and compensate for corneal spherical aberrations.	Procedure: phacoemulsification with implantation of presbyopia correcting IOL; cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
Active Comparator: Symphony EDOF (extended depth of focus) intraocular lens SYMPHONY EDOF intraocular lens is a single-piece aspheric biconvex hydrophobic acrylic IOL with a 6.0 mm optic and an 13.0 mm overall diameter. This IOL consists of a wavefront-designed anterior aspheric surface (negative spherical aberration of -0.27 mm to counterbalance the net positive spherical aberration from cornea) and a posterior achromatic diffractive surface with echelette design.	Procedure: phacoemulsification with implantation of presbyopia correcting IOL; cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. spectacle independence [6 months postoperatively.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daralshifa hospital	Kuwait		Kuwait

Sponsors and Collaborators

• Dar Al Shifa Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: magda torky, Principle investigator, Dar Al Shifa Hospital
• ClinicalTrials.gov Identifier: NCT04907955
• Other Study ID Numbers: 02282021065727
• First Posted: Jun 1, 2021
• Last Update Posted: Jun 1, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vision Disorders; Vision, Low; Presbyopia

Study Results

No Results Posted as of Jun 1, 2021