Search / Trial NCT06231784

Efficacy of the AkkoLens IOL in Patients With Cataract

Launched by VISSUM, INSTITUTO OFTALMOLÓGICO DE ALICANTE · Jan 26, 2024

Trial Information

Current as of December 22, 2024

Completed

Keywords

Intraocular Lens Accommodation

ClinConnect Summary

This is an observational, prospective, longitudinal, and consecutive study involving patients with clinical cataract eligible for cataract surgery who opt for the implantation of the Lumina (Akkolens, Clinical BV, The Netherlands) accommodative lens. The study was conducted at the Cornea, Cataract, and Refractive Surgery Unit in Vissum Alicante, Miranza Group, Spain. The study adhered to the tenets of the Declaration of Helsinki (2013 version )and was approved by the Comite Etico de Investigacion Clinica Vissum Alicante.

The study group included 50 eyes of 25 patients, aged 40 to 81 years ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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.

Trial Officials

Jorge Alio, MD, PhD

Principal Investigator

Vissum Instituto Oftalmologico de Alicante

About Vissum, Instituto Oftalmológico De Alicante

Vissum, Instituto Oftalmológico de Alicante, is a leading clinical research organization specializing in ophthalmology. With a commitment to advancing eye care through innovative research, Vissum conducts rigorous clinical trials aimed at evaluating cutting-edge treatments and technologies for a range of ocular conditions. The institute is equipped with state-of-the-art facilities and a team of experienced professionals dedicated to improving patient outcomes and contributing to the scientific community's understanding of vision-related health. Through collaboration with global partners, Vissum plays a pivotal role in shaping the future of ophthalmic therapies.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0