Evidence map›Paper›PMID 35968054›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2022

Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System.

Gabriel Quesada, Daniel H Chang, Kevin L Waltz, Andrew A Kao, Rodrigo Quesada, Ying Wang, Leilei Ji, Dari Parizadeh, Luis Atiles

Open access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Gabriel QuesadaGrupo Oftalmo & Plastico, San Salvador, El Salvador.
Daniel H ChangEmpire Eye and Laser Center, Bakersfield, CA, USA.ORCID 0000-0001-6307-6342
Kevin L WaltzCentral American Ophthalmic Research Consultants, Indianapolis, IN, USA.
Andrew A KaoEmpire Eye and Laser Center, Bakersfield, CA, USA.
Rodrigo QuesadaGrupo Oftalmo & Plastico, San Salvador, El Salvador.
Ying WangJohnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
Leilei JiJohnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
Dari ParizadehJohnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
Luis AtilesJohnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
Johnson & Johnson (United States) · USEmpire Eye Physicians · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability. Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5. Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥94% of cases regardless of cataract grade. Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.

Indexed as

cataractergonomicsfluidicssatisfactionVERITAS Vision System

Identifiers

PMID35968054
PMCPMC9365053
OpenAlexW4290005623

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.