Clinical Outcomes of an New EDOF IOL (Isopure®)

NCT ID: NCT05704686

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2021-12-31

Brief Summary

Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.

Detailed Description

This single-center retrospective study investigates visual outcomes and patient satisfaction in subjects bilaterally implanted with Enhanced-Depth of Focus (EDOF) Isopure® IOL during routine bilateral cataract surgery.

The study is carried out in an ophthalmic clinic in Switzerland. In this study, routine surgical techniques and postoperative follow-up will be applied as for all other (non-study) cataract patients in the clinic. Therefore, all study patients will be operated in immediate consecutive bilateral mode (routine in clinic). Patients participating in this study will be recruited and enrolled postoperatively. They undergo routine postoperative follow-up examinations, and data are collected at the third scheduled examination (4 to 6 weeks after surgery) and at a telephone call 4 to 6 months after surgery.

Isopure 1.2.3 is a CE certified intraocular lens readily available on the market in Switzerland.

The primary outcome consists in demonstrating a preserved distance visual acuity while improving binocular spectacle-free intermediate vision and, to a lesser extent, near vision. Binocular defocus curves are measured for each participant to simulate visual acuity at different distances. Patient satisfaction with treatment and subjective ratings of visual phenomena will be assessed using a modified PRISQ questionnaire and a modified NEI quality of vision questionnaire (RQL-42) at the third postoperative visit and three months after surgery.

At Vista Alpina Eye Clinic, mini-monovision is routinely used to further improve binocular intermediate and near vision while preserving the quality of distance vision in patients implanted bilaterally with EDOF Isopure® IOLs. Analysis of the retrospective data should help support this surgical strategy.

Patients with astigmatism up to 1.5 D benefit intraoperatively from Opposite Clear Corneal Incisions (OCCI) to reduce astigmatism. Analysis of our retrospective data will allow comparison of their visual performance with that of patients without astigmatism who did not require an additional OCCI procedure.

Conditions

Lens Opacities; Cataract; Pseudophakia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Isopure 1.2.3 intraocular EDOF lens implantation

Bilateral Isopure 1.2.3 intraocular EDOF IOL implantation during a routine cataract surgery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;
• Patient's willingness to participate in the study;
• Capacity to understand and sign an informed consent form and comply with examination procedures;
• Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);
• Regular total corneal astigmatism ≤1.5 D (measured by topography method)

Exclusion Criteria

• Cooperation difficulties (distance from home, general health conditions, cognitive impairment);
• Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);
• Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);
• History or presence of macular edema;
• Perioperative complications;
• Congenital, uveitic, traumatic or surgically-complicated cataract
• Regular total corneal astigmatism >1.5 dioptres (measured by topography method)
• Irregular cornea, including keratotomy

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kristof Vandekerckhove, MD, MBA

OTHER

Sponsor Role: lead

Responsible Party

Kristof Vandekerckhove, MD, MBA

Medical Director and Founder, Vista Alpina Eye Clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kristof Vandekerckhove, MD

Role: PRINCIPAL_INVESTIGATOR

Vista Alpina Eye Clinic

Locations

Vista Alpina Eye Clinic

Visp, , Switzerland

Countries

Switzerland

Other Identifiers

Iso123

Identifier Type: -

Identifier Source: org_study_id