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NCT07915076Not yet recruiting

Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.

Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Dry Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The goal of this clinical trial is to evaluate the safety, visual performance, and potential clinical benefits of the LENTIS® MAX LS-313 MF80 intraocular lens compared with the monofocal LENTIS® L-313 intraocular lens in adult patients with cataract in both eyes and clinically stable or inactive late age-related macular degeneration. The main questions it aims to answer are: 1. Is corrected distance vision with the LENTIS® MAX LS-313 MF80 not worse than corrected distance vision with the monofocal LENTIS® L-313? Is distance-corrected near vision with the LENTIS® MAX LS-313 MF80 not worse than, and potentially better than, near vision with the monofocal LENTIS® L-313? 2. Researchers will compare the two lenses within the same participant: each participant will receive the LENTIS® MAX LS-313 MF80 in one eye and the monofocal LENTIS® L-313 in the other eye. This will allow researchers to compare distance and near vision between the two eyes. Participants will: * undergo cataract surgery in both eyes, with implantation of the LENTIS® MAX LS-313 MF80 in one eye and the LENTIS® L-313 in the other eye; * attend postoperative follow-up visits, including the main assessment at 4-6 months and a longer-term assessment at 11-14 months after the first-eye surgery; * undergo eye examinations and vision testing, including distance and near visual acuity, refraction, eye-pressure measurements, retinal imaging, visual-field testing, and other ophthalmic examinations; and * complete study-specific assessments of vision-related quality of life and activities of daily living and perform a home-based visual training programme following implantation of the LENTIS® MAX LS-313 MF80.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
35 (estimated)
First submitted
19 Oct 2026
Start date
1 Feb 2027
Primary completion date
1 Mar 2030
Lead sponsor
Teleon Surgical B.V.
NCT number
NCT07915076

What you commit to

  • Study type: Interventional
  • Planned participants: 35
  • From 1 Feb 2027 to the primary completion date, 1 Mar 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intravitreal treatment within the previous 12 weeks.
  • Anterior segment pathology that could increase surgical risk or compromise lens stability.
  • Active infectious conjunctivitis, keratitis, or uveitis within 30 days before surgery.
  • Participation in another drug or medical-device investigation within the previous 30 days.

Other illness

  • Degenerative visual disorders expected to significantly affect visual acuity.
  • Ocular surface disease or clinically significant dry eye.
  • Chronic or recurrent inflammatory eye disease.
  • Pseudoexfoliation syndrome.
  • History of intraocular inflammation/uveitis.
  • Acute ocular, internal, external, or systemic infection.
  • Neurological disorders or other conditions that prevent adequate fixation.

Age

  • Active neovascular age-related macular degeneration.
  • Markedly asymmetric age-related macular degeneration severity between the two eyes that would prevent meaningful comparison.
  • Active late wet age-related macular degeneration or evidence of new intraretinal fluid, subretinal fluid, macular haemorrhage, or other active neovascular disease.
  • Other ocular or systemic conditions expected to influence visual outcomes, other than age-related macular degeneration.

Other

  • Photopic pupil size \<2 mm or \>6 mm.
  • Irregular astigmatism in either eye.
  • Unstable keratometry or biometry measurements.
  • Anterior corneal cylinder \>1.5 D in either eye.
  • Traumatic cataract.
  • Amblyopia.
  • History or presence of macular oedema.
  • Pupil abnormalities.
  • Clinically significant uncontrolled glaucoma that could affect visual outcomes.
  • Diabetic retinopathy.
  • Congenital ocular anomalies.
  • Only one functioning eye.
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception where applicable.

Who the study is looking for

  • Adult patients, maximum 85 years old on the day of surgery.
  • Current or previous use of, or documented need for, external near-vision magnification aids.
  • Bilateral late age-related macular degeneration, classified according to NICE as: late dry age-related macular degeneration, or late wet inactive age-related macular degeneration, without clinical or optical coherence tomography evidence of active exudation for at least 12 weeks before enrolment.
  • Cataract in both eyes.
  • Need for bilateral intraocular lens implantation with the investigational lens in one eye and the monofocal comparator in the other.
  • Clear intraocular media other than cataract.
  • Preoperative corrected near visual acuity of 0.6 logMAR or worse in each eye.
  • Planned postoperative refraction between -0.5 D and 0.0 D.
  • Required intraocular lens power within the available ranges.
  • Ability to understand the study procedures, provide informed consent and reliably complete visual-function assessments.
  • Signed informed consent form.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.