Dataset Information

Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract.

ABSTRACT:

Background

The aim was to evaluate the safety and efficacy of a trifocal intraocular lens (IOL) for the correction of presbyopia and to assess patient satisfaction.

Methods

Records from three centres were reviewed to select presbyopic patients having undergone bilateral refractive lens exchange and implantation of the AT LISA tri 839MP multifocal IOL. Postoperatively, monocular and binocular distance, intermediate and near visual acuities, corrected and uncorrected, and subjective refraction were measured. Patients also completed a quality of life questionnaire. Safety evaluation included IOL stability and postoperative complications.

Results

72 eyes (36 patients) were analysed. No clinically significant difference between pre- and postoperative corrected distance visual acuity (CDVA) was found for monocular or binocular measurements. Mean postoperative monocular CDVA was 0.02 ± 0.04 logMAR. Mean refractive values all improved statistically significantly compared with preoperative baseline (p ≤ 0.0064). Overall, 82.4% of eyes had spherical equivalent within ± 0.5 D and 97.1% within ± 1.0 D of emmetropia with a mean accuracy of -0.10 ± 0.41 D. Spectacle independence for distance, intermediate and near visual acuity was 87.5%, 84.4% and 78.1% respectively, and 78.1% of patients were satisfied with their postoperative, spectacle-free vision. Eight eyes received Nd:YAG laser treatment. No other IOL-related safety issues were reported.

Conclusion

AT LISA tri 839MP multifocal IOL bilaterally implanted in presbyopic patients provided excellent distance, intermediate and near visual outcomes with very accurate correction of refraction. These results were associated with a high level of spectacle independence and patient satisfaction.

Trial registration

Trial registered on https://clinicaltrials.gov/ under the identification NCT03790592 (31/12/2018).

SUBMITTER: Fernandez J

PROVIDER: S-EPMC9364506 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract.

Fernández Joaquín J Alfonso Sánchez José F JF Nieradzik Mark M Valcárcel Beatriz B Burguera Noemí N Kapp Alexander A

BMC ophthalmology 20220810 1

<h4>Background</h4>The aim was to evaluate the safety and efficacy of a trifocal intraocular lens (IOL) for the correction of presbyopia and to assess patient satisfaction.<h4>Methods</h4>Records from three centres were reviewed to select presbyopic patients having undergone bilateral refractive lens exchange and implantation of the AT LISA tri 839MP multifocal IOL. Postoperatively, monocular and binocular distance, intermediate and near visual acuities, corrected and uncorrected, and subjective ...[more]

PMID: 35948879

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Project description:IntroductionRefractive lens exchange (RLE) patients represent a unique population with a different baseline and set of expectations compared to their cataract counterparts. Visual outcomes and patient satisfaction following RLE with bilateral implantation of a trifocal intraocular lens (IOL) were assessed in a cohort of patients with presbyopia and without cataract.MethodsCharts of patients with presbyopia who underwent femtosecond laser-assisted RLE with bilateral implantation of the PanOptix trifocal IOL (toric and non-toric) at a single-surgeon, private practice center from September 2019 to August 2020 were retrospectively reviewed. Eyes with prior keratorefractive surgery, amblyopia, or underlying pathology were excluded. Primary endpoints included corrected and uncorrected visual acuity at distance (CDVA and UDVA), intermediate (DCIVA and UIVA), and near (DCNVA and UNVA) at 6 months. Secondary endpoints included residual refractive error, patient-reported satisfaction, spectacle independence, and visual disturbance profile as assessed by a validated questionnaire at 6 months.ResultsSeventy-eight eyes of 39 patients (mean age 56 ± 6 years; 79% female) were included. Most eyes were hyperopic (mean SE 2.35 ± 1.81). Postoperatively, 100% and 92% of eyes were within ± 1.00 D and ± 0.50 D of emmetropia, respectively. One hundred percent, 97%, and 97% of patients achieved UDVA, UNVA, and UIVA of logMAR 0.1 or better. Starbursts were the most frequent (67%) and bothersome (41%) visual disturbance cited, but nearly half (41%) of patients rated them as absent or "not bothersome at all." Overall, 77% of patients reported achieving complete spectacle independence with 87% and 90% of patients stating they were satisfied with their vision and would recommend the same procedure to others, respectively.ConclusionsRLE with bilateral implantation of the PanOptix IOL is a safe and effective procedure with good patient satisfaction. Because of their relatively clear native lenses and visually demanding needs compared to their cataract counterparts, surgeons should take extra precautions to counsel RLE patients on the limitations of trifocal technology.

Project description:PurposeTo evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof® IQ PanOptix® (TFNT00), in an Indian population.Patients and methodsThis prospective, multicenter, observational, single-arm, post-marketing study included 67 patients undergoing cataract surgery with bilateral implantation of TFNT00 across five Indian sites. Postoperative outcomes were assessed at 3 months after second eye surgery. Effectiveness outcomes included: mean binocular and monocular visual acuity (VA) at distance (4 m), intermediate (60 cm), and near (40 cm); binocular defocus curve; manifest refraction; and subjective symptom questionnaire evaluation. Safety outcomes included the rate of ocular adverse events and mesopic contrast sensitivity.ResultsMean binocular and monocular distance-corrected and uncorrected VAs of 0.1 logMAR or better (approximately 20/25 Snellen) were achieved at distance, intermediate, and near. Overall, ≥70% of patients achieved binocular 0.1 logMAR vision or better across all distances. TFNT00 maintained a mean VA of 0.1 logMAR or better at the defocus range of +0.5 diopters (D) to -2.5 D (200 cm to 40 cm). The subjective symptom questionnaire-assessed frequency of halo visual disturbances was low at Month 3; halos were reported "none of the time" to "only some of the time" in 86.6% of patients. The large majority of patients (98.5%) were "satisfied" or "very satisfied" with their near, intermediate, and distance vision at Month 3, and ≥94.0% of patients reported spectacle independence for tasks at all distances. The adverse event rate was low; no patients discontinued due to an adverse event.ConclusionTFNT00 provided a continuous range of vision of 20/25 or better for distance to near and performed effectively at an intermediate functional distance of 60 cm, resulting in high levels of spectacle independence and patient satisfaction. TFNT00 demonstrated a good safety profile and a low post-operative frequency of halo visual disturbances.

Dataset Information

Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract.

Background

Methods

Results

Conclusion

Trial registration

Publications

Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract.

Similar Datasets

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