Efficacy of the AkkoLens IOL in Patients With Cataract

January 26, 2024 updated by: Jorge Alio, Vissum, Instituto Oftalmológico de Alicante

Prospective, Open-label Clinical Study to Evaluate the Efficacy and Function of the AkkoLens Accommodative Intraocular Acrylic Lens for the Treatment of Cataracts

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (mean 62.27 ± 10.81 years), with clinical cataract who were implanted with the Lumina accommodative IOL. The inclusion criteria of this study were as follows: patients with visual significant cataract with an expected positive effect of the surgery on the visual outcome. The patient had to be ≥ 40 years of age and with a calculated IOL power within the available diopter range. The exclusion criteria were 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 or significant eye trauma that may induce lens instability, congenital ocular anomalies, endothelial cell count < 1200 cells/mm2 and previous known reading disabilities such as dyslexia. Only patients with less than 2 diopters (D) of corneal astigmatism were included in the study with no significant corneal irregularities (less than 0.5 microns of anterior corneal surface HOA) as measured by corneal topography (CSO, Costruzione Strumenti Oftalmici, Firenze, Italy). All patients were adequately informed and signed a consent form.

Preoperatively, all patients had a full ophthalmologic examination including the evaluation of the refractive status, keratometry, the distance and near visual acuities, slit lamp examination, applanation tonometry, and funduscopy. Distance and near visual acuity were measured with the ETDRS and the Radner reading chart (logarithm of reading acuity determination, logRAD), respectively. Other examinations included corneal topography Sirius/MS-39 (CSO, Costruzione Strumenti Oftalmici, Firenze, Italy), anterior segment optical coherence tomography MS-39 (CSO, Costruzione Strumenti Oftalmici, Firenze, Italy) or Casia2 (Tomey, Japan), posterior segment optical coherence tomography Cirrus OCT (Zeiss, Germany) and biometry IOL master 700 (Zeiss, Germany). The fixed optical power of the lens (i.e., the power required for an emmetropic eye) was calculated from optical biometry (IOL Master; Zeiss) by using proprietary Cþþ software integrated with Zemax ray-tracing software (Zemax, USA). The target refraction was plano in all cases that were included.

The same surgeon (JLA) performed all surgeries. All patients received retrobulbar anesthesia and mild sedation with midazolam. Adequate dilatation was obtained with intracameral mydriatics. The main corneal incision of 2.8 mm was placed temporally at the 180° meridian position in all eyes. 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. Postoperative topical therapy included a combination of topical antibiotics (ofloxacin 0.3%) and a steroid agent (dexamethasone 0.1%, Maxidex; Alcon, Spain).

The patients were evaluated during the follow up at five intervals: 1 day, 1 month, 3 months 6 months and a minimum of 12 months after surgery. In addition to the measurements listed in the preoperative protocol, the postoperative protocol included additional assessments of contrast sensitivity function in mesopic conditions (CSV 1000, VectorVision Ocular Health, Greenville, Ohio, USA) and the defocus curves. Monocular defocus curves were obtained with best distance refractive correction under low ambient light to keep an open pupil to minimize the undesirable effect of extended depth of focus owing to a small pupil, which can mask true accommodation. Negative and positive spherical lenses were added in 0.50 D steps, producing a stimulus for the eye to accommodate in the range from -5.00 to +2.00 D. The means of the measured visual acuities are summarized in mean defocus curves in which the measurements at 0.00 D and-2.50 D correspond to corrected distance visual acuity (CDVA) and corrected distance near visual acuity (CDNVA), respectively, and intermediate visual acuity corresponds to the measurement at -1.50 D. Depth of focus was evaluated from defocus curves at the levels of visual acuity of 0.10, 0.20, and 0.40 logMAR. The depth of focus for a particular eye was defined as the width of the defocus curve, in diopters, at a given level of visual acuity. The retinal optical quality was obtained using pyramidal aberrometry (Osiris, CSO, Italy) and optical quality analyzer system (OQAS, Visiomettrics SL, Spain) obtaining the MTF and PSF for different diameters and open field aberrometer (OFA, CSO, Italy) measured for distance and near.

Main outcome measures Primary: Distance and near visual acuities, defocus curve, accommodation, depth of focus.

Secondary: Contrast sensitivity function, optical quality assessment, PROMs (quality of vision and quality of life reported by the patients), complications.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lumina Implantation
Patients implanted with LUMINA IOL
Device: LUMINA IOL
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance Vision measurements
Time Frame: minimum 12 months
Distance and near visual acuities in LogMAR scale
minimum 12 months
Defocus curve measurements
Time Frame: minimum 12 months
Defocus curve in diopters
minimum 12 months
Accommodation measurements
Time Frame: minimum 12 months
Accommodation in diopters
minimum 12 months
Depth of focus measurements
Time Frame: minimum 12 months
Depth of focus in diopters
minimum 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast sensitivity function
Time Frame: minimum 12 months
Contrast sensitivity function in cycles per degrees
minimum 12 months
Optical quality assessment
Time Frame: minimum 12 months
Optical quality assessment in microns, PROMs (quality of vision and quality of life reported by the patients) considering a score from 1 (the best situation) to 5 (the worst situation)
minimum 12 months
Complications
Time Frame: minimum 12 months
Complications not requiring units of measure
minimum 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vissum, Instituto Oftalmológico de Alicante

Collaborators

AkkoLens Clinical bv

Investigators

  • Principal Investigator: Jorge Alio, MD, PhD, VISSUM Instituto Oftalmológico de Alicante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2016

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lumina

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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