An observational study in Intraocular Lens, Cataract and Quality of Life, sponsored by Baskent University Ankara Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Baskent University Ankara Hospital · Observational
The purpose of this study is to compare visual performance and quality of life (QOL) following bilateral implantation of a novel non-diffractive extended depth-of-focus (EDOF) intraocular lens (IOL) (AcrySof® IQ Vivity, Alcon, TX, USA) and a trifocal IOL (Acrysof® IQ PanOptix, Alcon, Fort Worth, TX) in a prospective comparative interventional case series.
Developments in cataract surgical devices and intraocular lenses (IOL) increased patient expectations and changed the practice patterns in ophthalmology. Nowadays, cataract surgery is considered as a refractive surgery. With multifocal IOLs, spectacle independence can be achieved with a good distance, intermediate and near visual acuity. This is associated with increased quality of life after cataract surgery.The most important disadvantages of multifocal IOLs are loss of contrast sensitivity and photic phenomena such as glare and halo. Although multifocal IOLs are more frequently associated with photic disturbances than monofocal IOLs, the trifocal IOLs have improved performance in photic phenomena when compared to bifocal IOLs. Recently, a new technology known as extended depth of focus (EDOF) IOLs have been developed. These lenses create a single elongated focal point to enhance the depth of focus, improving intermediate vision without compromising distance vision. Although EDOF IOLs provide better intermediate distance vision when compared to monofocal IOLs, near vision is not as good as trifocal IOLs. The most important advantage provided by the EDOF technology is lower rate of photic disturbances than trifocal IOL designs. The aim of this study was to compare the visual performance and patient-reported quality of life (QOL) outcomes following bilateral implantation of a novel non-diffractive wavefront shaping EDOF IOL (AcrySof® IQ Vivity, Alcon Research, TX, USA) and a trifocal IOL (AcrySof® IQ PanOptix, Alcon Laboratories, Fort Worth, TX).
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 52 is below the median of 81 across 484 observational studies indexed under Cataract.
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104 eyes of 52 consecutive patients with bilateral cataracts operated between April and September 2021 were included. All patients were interested in spectacle independence. Each participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well.
Exclusion Criteria:
Patients who were implanted with the novel wavefront shaping extended depth of focus IOL
Device: İntraocular lens implantation
Patients who were implanted with the multifocal IOL
Device: İntraocular lens implantation
Each participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The interval between the first and second-eye surgeries was 1 to 3 weeks. The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well.
Postoperative visual acuity with or without spectacle correction at near, far and intermediate distances
uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), distance corrected intermediate visual acuity (DCIVA), distance corrected near visual acuity (DCNVA)
Time frame: postoperative third month
Defocus-curves
The monocular defocus curves were evaluated under photopic conditions using defocusing lenses from +0.50 D to -4.00 D in 0.50 D steps. The measurements were performed by adding the lenses to the CDVA.
Time frame: postoperative third month
Contrast sensitivity
Monocular and binocular contrast sensitivity was assessed with the Pelli-Robson chart under photopic conditions at 3 meters.
Time frame: postoperative third month
Reading speed
Reading speed was measured using the validated Turkish version of the MNREAD chart in photopic illumination conditions. It was recorded as number of words read by the patient in one minute (words per minute-wpm).
Time frame: postoperative third month
Quality of vision / dysphotopsia
Dysphotopsia was assessed by the Quality of Vision (QoV) questionnaire developed by McAlinden et al. The QoV is a validated Rasch-adjusted questionnaire in which patients are asked to rate specific dysphotopsia items depicted in standard photographs. Patients score each item (0, 1, 2, or 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total). Lower QoV scores indicate a better quality of vision.
Time frame: postoperative third month
Vision-related quality of life (QOL)
The vision-related QOL was assessed three months after the surgery by the VF-14 QOL questionnaire that was administered face-to-face by a trained researcher (İK). The grading scale was as follows: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Special care was taken not to influence the patients and to ensure that each question was fully understood.
Time frame: postoperative third month
Plan to share: Undecided — Data will be available upon request.
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Baskent University Ankara Hospital