Dataset Information

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.

ABSTRACT:

Purpose

To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF.

Setting

19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom.

Design

Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study.

Methods

Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6.

Results

282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was <0.1 logMAR) and superior mean DCNVA (95% UCL of the difference was <0.0 logMAR) compared with SN60WF at month 6. DFT015 exhibited a similar visual disturbance profile to that of SN60WF.

Conclusions

DFT015 provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.

SUBMITTER: Bala C

PROVIDER: S-EPMC8845530 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.

Bala Chandra C Poyales Francisco F Guarro Mercè M Mesa Ramón Ruiz RR Mearza Ali A Varma Devesh Kumar DK Jasti Srichand S Lemp-Hull Jessie J

Journal of cataract and refractive surgery 20220201 2

<h4>Purpose</h4>To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF.<h4>Setting</h4>19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom.<h4>Design</h4>Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study.<h4>Methods</h4>Participants aged ≥22 years with bilateral cataracts were randomized ...[more]

PMID: 34288635

Similar Datasets

Project description:Fuchs endothelial corneal dystrophy (FECD) is considered a contraindication for the implantation of presbyopia-correcting IOLs, without sufficient corroborating evidence. A Retrospective, case-control study. Nineteen eyes of ten patients with grade 2-5 FECD (study group) and 57 healthy eyes of 57 patients (control group) who underwent cataract surgery with implantation of presbyopia-correcting IOLs, at the Ein-Tal Eye Center, Tel Aviv, Israel, were included. The target refraction was emmetropia for both groups. Two subgroups of IOLs were analyzed separately: extended depth of focus (EDOF), (9 eyes of FECD patients and 27 eyes of control patients) and multifocal IOLs (10 eyes of FECD patients and 30 eyes of control patients). Main outcome measures were visual acuity and refraction 6 weeks after the surgery. Secondary outcomes were patient perceptions of visual acuity, spectacle independence, photic phenomena and satisfaction scores, reported in a self-assessment questionnaire. FECD patients in the EDOF IOL subgroup had inferior uncorrected distance visual acuity (P = 0.007) and better uncorrected near visual acuity (P = 0.001) compared to the controls. They had less spectacle independence for the intermediate range (P = 0.01) and overall (P = 0.006). However, they did not have more photic phenomena. In the multifocal IOL subgroup, no significant differences were found between the FECD and the control group in visual acuity for all ranges and in spectacle independence. FECD patients had more photic phenomena than the controls (P = 0.006), but it did not interfere with daily life activities. There was no difference in post-operative mean spherical equivalent, patient reported visual perception, and general satisfaction between FECD and control patients in both groups. Our results suggest that presbyopia-correcting IOLs can be carefully considered in patients with grade 2-5 FECD, with slightly inferior results compared with healthy eyes.

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.

Project description:IntroductionPresbyopia-correcting intraocular lens (PCIOL) implantation is a popular treatment option for cataract surgery patients who desire spectacle independence. This study aimed to understand patient perception and outcomes with PCIOLs by analyzing patient social media posts.MethodsThis was a non-interventional retrospective study that used predefined search strings to identify publicly available social media data discussing patient perceptions and outcomes with seven PCIOLs (three trifocal, one multifocal with continuous range of vision, and three extended depth-of-focus [EDOF] PCIOLs). Relevant posts were searched from Reddit, YouTube, and Facebook and patient forums Patient.info, Medicine.net, Optiker-Forum, and Medizin Forum from September 2020 to October 2022 in four languages (English, German, French, and Spanish).ResultsA total of 2237 posts were included, all in English, with 68% of posts identified on Patient.info. The themes most discussed by patients were quality of vision (69% of total posts), patient experience after PCIOL implantation (30%), patient perception before PCIOL implantation (26%), and visual disturbances (24%). Most discussed PCIOLs were Vivity® (58% of total posts), PanOptix® (38%), Synergy® (26%), and Symfony® (13%). Patient perception of PCIOLs was most frequently influenced by healthcare professionals, online reading, and online videos (31%, 18%, and 15% of posts, respectively). A total of 215 posts (10% of total) discussed glasses use after PCIOL surgery: for EDOF and trifocal/multifocal PCIOLs, 37% and 56% of posts discussing glasses use stated being glasses free, respectively. A total of 537 posts discussed visual disturbances: halos/rings (66%) and starbursts (36%) were the most discussed visual disturbances for all lens types. Being glasses free after PCIOL implantation appeared to be a key driver of patient satisfaction.ConclusionSocial media provides a rich source of information on patient perception, experience, and overall satisfaction of PCIOLs that can be used to complement and guide the collection of further evidence generated through controlled trials.

Dataset Information

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.

Purpose

Setting

Design

Methods

Results

Conclusions

Publications

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets