Efficacy of the AkkoLens IOL in Patients With Cataract

NCT06231784 | Completed

• 1 other identifier: Lumina
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn about the verification of the effectiveness and visual acuity of LUMINA in patients after lens replacement due to cataracts. The main questions it aims to answer are:

• Evaluation of the effectiveness of the LUMINA lens in patients after lens replacement due to cataracts
• Evaluation of the accommodative power of the LUMINA lens. Participants will have cataract surgery and the IOL LUMINA will be implanted in the sulcus.

Conditions

Cataract

Keywords

Intraocular lens; Accommodation

Outcome Measures

Primary Outcomes (4)

• Distance Vision measurements

  Distance and near visual acuities in LogMAR scale

  minimum 12 months

• Defocus curve measurements

  Defocus curve in diopters

  minimum 12 months

• Accommodation measurements

  Accommodation in diopters

  minimum 12 months

• Depth of focus measurements

  Depth of focus in diopters

  minimum 12 months

Secondary Outcomes (3)

• Contrast sensitivity function

  minimum 12 months

• Optical quality assessment

  minimum 12 months

• Complications

  minimum 12 months

Study Arms (1)

Lumina Implantation

OTHER

Patients implanted with LUMINA IOL

Device: LUMINA IOL

Interventions

LUMINA IOL DEVICE

A standard technique of phacoemulsification was performed followed by implantation of the Lumina in the sulcus plane of the eye by using a standard disposable injector system with an adapted, proprietary, AkkoLens butterfly cartridge.

Lumina Implantation

Eligibility Criteria

• Age: 40 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual significant cataract with an expected positive effect of the surgery on the visual outcome.
• ≥ 40 years of age
• Calculated IOL power within the available diopter range

You may not qualify if:

• Comorbidities causing postoperative visual impairment, such as degenerative macular pathology
• Glaucoma with optic disk damage and visual field loss
• Retinal dystrophies
• Previous ocular surgeries, such as vitrectomy, corneal graft surgery
• Lens subluxation
• Significant eye trauma that may induce lens instability
• Congenital ocular anomalies
• Endothelial cell count \< 1200 cells/mm2
• Previous known reading disabilities, such as dyslexia.

Sponsors & Collaborators

• Vissum, Instituto Oftalmológico de Alicante: lead
• AkkoLens Clinical bv: collaborator

Related Publications (2)

• Alio JL, Simonov A, Plaza-Puche AB, Angelov A, Angelov Y, van Lawick W, Rombach M. Visual Outcomes and Accommodative Response of the Lumina Accommodative Intraocular Lens. Am J Ophthalmol. 2016 Apr;164:37-48. doi: 10.1016/j.ajo.2016.01.006. Epub 2016 Jan 29.

  PMID: 26829595 BACKGROUND

• Alio JL, Simonov AN, Romero D, Angelov A, Angelov Y, van Lawick W, Rombach MC. Analysis of Accommodative Performance of a New Accommodative Intraocular Lens. J Refract Surg. 2018 Feb 1;34(2):78-83. doi: 10.3928/1081597X-20171205-01.

  PMID: 29425385 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Jorge Alio, MD, PhD

  Vissum Instituto Oftalmologico de Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: LUMINA IOL

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 30, 2024
• Study Start: June 9, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share