PMCF Retrospective Study Outcomes of a Monofocal Toric Intraocular Lens

NCT05055076 | Completed

• 1 other identifier: PHY2120
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations. The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations. The investigator is an accredited and experienced cataract surgeon and researcher. The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.

Conditions

Cataract; Lens Opacities; Astigmatism

Keywords

Intraocular Lens; Monofocal; Toric Lens

Outcome Measures

Primary Outcomes (1)

• Rotational Stability

  Rotational stability is an important parameter on toric IOLs, as postoperative IO L rotation can lead to inappropriate correction of corneal astig matism and decrease in uncorrected distance visual acuity. The primary study endpoint is the absolute value of rotation between the day of surgery and the postoperative visit 6 months after surgery. The absolute value of rotation should be less than 10° in 90% of the eyes implanted with POD EYE TORIC lens according to safety declarations of EN ISO 11979-7:2018.

  6 months

Secondary Outcomes (1)

• Stability of Manifest Refraction (Spherical Equivalent)

  6 months

Other Outcomes (2)

• Corrected and Uncorrected Distance Visual Acuity

  6 months

• Refractive astigmatism predictability

  6 months

Study Arms (1)

PODEYE TORIC

Adult patients who have undergone cataract surgery with mono- or bilateral implantation of POD EYE TORIC IOL (POD T 49P) and who meet all the inclusion and exclusion criteria will be invited to participate in the study.

Device: PODEYE TORIC

Interventions

PODEYE TORIC DEVICE

Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.

PODEYE TORIC

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who have undergone cataract surgery with mono- or bilateral implantation of POD EYE TORIC IOL (POD T 49P) and who meet all the inclusion and exclusion criteria will be invited to participate in the study. Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.

You may qualify if:

• Male or female adults aged 35 years or older on the day of treatment that were mono- or bilaterally implanted with PODEYE TORIC intraocular lens
• Capable of understanding the patient informed leaflet;
• Complete data available at the screening visit, surgical visit and at least one postoperative visit.

You may not qualify if:

• Age of patient \<35 years at the day of surgery;
• Subjects who underwent previous intraocular or corneal surgery other than IO L implantation;
• Subjects in whom in-the-bag implantation was not possible;
• Subjects in whom surgical complications occurred (e.g. posterior rupture);

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (1)

Clinique Beau Soleil

Montpellier, 34070, France

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: August 1, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)