Dataset Information

Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.

ABSTRACT:

Purpose

To evaluate the rheological properties of the ophthalmic viscoelastic device (OVD) PRO-149, its preclinical safety, and its effectiveness when used during cataract surgery in patients with age-related cataract.

Material and methods

Control (HEC) and test (PRO-149) OVDs were compared through rheological measures, by two preclinical safety studies in rabbits, and under normal-use conditions during cataract removal and lens implantation in a parallel randomized clinical trial.

Results

Rheological properties were determined. Preclinical studies did not find any evidence of safety issues or toxicity. In the clinical trial, 36 subjects were included. After 29 days, there were no statistically significant differences in mean percentage of endothelial cell count change or in the postoperative intraocular pressure between groups. There were no significant differences between OVDs for any safety parameter studied. Finally, PRO-149 showed a statistically significant improvement in surgeon rating for ease of use during extraction (p < 0.05).

Conclusion

PRO-149 is a dispersive OVD. The rabbit models did not find evidence of clinical alterations or toxicity. The results of the clinical study support that the two studied OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.

Trial registration

The trial is registered at Clinical Trials.gov at NCT04702802 (21-01-11).

SUBMITTER: Palacio-Pastrana C

PROVIDER: S-EPMC9421612 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.

Palacio-Pastrana Claudia C Muñoz-Villegas Patricia P Dániel-Dorantes Fernando F Sánchez-Ríos Alejandra A Olvera-Montaño Oscar O Martínez-Montoya Yareni I YI Quintana-Hau Juan D JD Baiza-Durán Leopoldo M LM

Medical devices (Auckland, N.Z.) 20220824

<h4>Purpose</h4>To evaluate the rheological properties of the ophthalmic viscoelastic device (OVD) PRO-149, its preclinical safety, and its effectiveness when used during cataract surgery in patients with age-related cataract.<h4>Material and methods</h4>Control (HEC) and test (PRO-149) OVDs were compared through rheological measures, by two preclinical safety studies in rabbits, and under normal-use conditions during cataract removal and lens implantation in a parallel randomized clinical trial ...[more]

PMID: 36046598

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Project description:ImportanceCataract is an important cause of visual impairment in children. Data from a large pediatric cataract surgery registry can provide real-world estimates of visual outcomes and the 5-year cumulative incidence of adverse events.ObjectiveTo assess visual acuity (VA), incidence of complications and additional eye operations, and refractive error outcomes 5 years after pediatric lensectomy among children younger than 13 years.Design, setting, and participantsThis prospective cohort study used data from the Pediatric Eye Disease Investigator Group clinical research registry. From June 2012 to July 2015, 61 eye care practices in the US, Canada, and the UK enrolled children from birth to less than 13 years of age who had undergone lensectomy for any reason during the preceding 45 days. Data were collected from medical record reviews annually thereafter for 5 years until September 28, 2020.ExposuresLensectomy with or without implantation of an intraocular lens (IOL).Main outcomes and measuresBest-corrected VA and refractive error were measured from 4 to 6 years after the initial lensectomy. Cox proportional hazards regression was used to assess the 5-year incidence of glaucoma or glaucoma suspect and additional eye operations. Factors were evaluated separately for unilateral and bilateral aphakia and pseudophakia.ResultsA total of 994 children (1268 eyes) undergoing bilateral or unilateral lensectomy were included (504 [51%] male; median age, 3.6 years; range, 2 weeks to 12.9 years). Five years after the initial lensectomy, the median VA among 701 eyes with available VA data (55%) was 20/63 (range, 20/40 to 20/100) in 182 of 316 bilateral aphakic eyes (58%), 20/32 (range, 20/25 to 20/50) in 209 of 386 bilateral pseudophakic eyes (54%), 20/200 (range, 20/50 to 20/618) in 124 of 202 unilateral aphakic eyes (61%), and 20/65 (range, 20/32 to 20/230) in 186 of 364 unilateral pseudophakic eyes (51%). The 5-year cumulative incidence of glaucoma or glaucoma suspect was 46% (95% CI, 28%-59%) in participants with bilateral aphakia, 7% (95% CI, 1%-12%) in those with bilateral pseudophakia, 25% (95% CI, 15%-34%) in those with unilateral aphakia, and 17% (95% CI, 5%-28%) in those with unilateral pseudophakia. The most common additional eye surgery was clearing the visual axis, with a 5-year cumulative incidence of 13% (95% CI, 8%-17%) in participants with bilateral aphakia, 33% (95% CI, 26%-39%) in those with bilateral pseudophakia, 11% (95% CI, 6%-15%) in those with unilateral aphakia, and 34% (95% CI, 28%-39%) in those with unilateral pseudophakia. The median 5-year change in spherical equivalent refractive error was -8.38 D (IQR, -11.38 D to -2.75 D) among 89 bilateral aphakic eyes, -1.63 D (IQR, -3.13 D to -0.25 D) among 130 bilateral pseudophakic eyes, -10.75 D (IQR, -20.50 D to -4.50 D) among 43 unilateral aphakic eyes, and -1.94 D (IQR, -3.25 D to -0.69 D) among 112 unilateral pseudophakic eyes.Conclusions and relevanceIn this cohort study, development of glaucoma or glaucoma suspect was common in children 5 years after lensectomy. Myopic shift was modest during the 5 years after placement of an intraocular lens, which should be factored into implant power selection. These results support frequent monitoring after pediatric cataract surgery to detect glaucoma, visual axis obscuration causing reduced vision, and refractive error.

Project description:Purpose:To assess the efficacy and safety of a novel ophthalmic viscosurgical device-free (OVD-free) method for posterior chamber phakic intraocular lens (PIOL) implantation in myopic eyes. Methods:In this retrospective cohort study, the medical records of myopic eyes that underwent PIOL (Implantable Collamer Lens, ICL) implantation for myopia correction at the Eye Hospital of Wenzhou Medical University between May 2015 and March 2017 were reviewed. A total of 49 eyes with complete data that met follow up requirements (2?h, 1?day, 1?week, 3?months postoperatively) were recruited. Based on the surgical techniques used, the eyes were divided into the OVD-free method group and the standard method group. The clinical data, including intraocular pressure (IOP), corrected distance visual acuity (CDVA) and spherical equivalent (SE), at each follow-up were collected for comparison. Endothelial cell loss and complications were also investigated. Results:Twenty-one eyes received the standard method, and 28 eyes received the OVD-free method. A rise in IOP >?22?mmHg at 2?h was noted in 14 eyes (66.7%) in the standard group and none (0%) in the OVD-free group (p?<?0.001). The rise in IOP from baseline was significantly higher at 2?h in the standard group (10.5?±?5.2?mmHg vs. 2.2?±?3.3?mmHg, difference: 8.3, 95% CI 5.8 to 10.8; p <?0.001). There was a significant difference in the time course of LogMAR CDVA changes between the two groups (p?=?0.047). The LogMAR CDVA was significantly better in the OVD-free method group compared to the standard group at 1?day (-?0.076, 95% CI -?0.134 to -?0.018; p?=?0.012), 1?week (-?0.071, 95% CI -?0.135 to -?0.007; p?=?0.03), but not at 3?months (-?0.046, 95% CI -?0.107 to 0.015; p?=?0.134). There was no significant difference in the time course of SE changes between the two groups (p?=?0.471; p?=?0.705). In the OVD-free group, mean endothelial cell loss was 4.6% at 3?months (2522?±?281 vs. 2407?±?226 cells/mm2, difference: -115, 95% CI -?295 to 65; p?=?0.187). No complications were reported in both groups except for the early IOP elevation in the standard group during the observation period. Conclusions:The OVD-free method is safe and efficient for ICL implantation. It can be a safer method of ICL implantation compared to the standard method in that it completely eliminates ophthalmic viscoelastic devices-related complications without causing additional complications.

Dataset Information

Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.

Purpose

Material and methods

Results

Conclusion

Trial registration

Publications

Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.

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