Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06231784 |
| Other study ID # |
Lumina |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 9, 2016 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Vissum, Instituto Oftalmológico de Alicante |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
