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Not yet recruitingNCT07915076Updated Nov 4, 2026

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.

An interventional study of Intraocular Lens in Cataract and AMD - Age-Related Macular Degeneration, sponsored by Teleon Surgical B.V.. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Teleon Surgical B.V. · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Cataract
  • AMD - Age-Related Macular Degeneration
03

In context

Cataract

1,731 studies on the registry are indexed under Cataract; 233 are open to participants now.

This study's planned enrollment of 35 is below the median of 79 across 1,174 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Teleon Surgical B.V. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Photopic pupil size \<2 mm or >6 mm.
  • Active neovascular age-related macular degeneration.
  • Markedly asymmetric age-related macular degeneration severity between the two eyes that would prevent meaningful comparison.
  • Intravitreal treatment within the previous 12 weeks.
  • Active late wet age-related macular degeneration or evidence of new intraretinal fluid, subretinal fluid, macular haemorrhage, or other active neovascular disease.
  • Irregular astigmatism in either eye.
  • Unstable keratometry or biometry measurements.
  • Anterior corneal cylinder >1.5 D in either eye.
  • Traumatic cataract.
  • Amblyopia.
  • Degenerative visual disorders expected to significantly affect visual acuity.
  • History or presence of macular oedema.
  • Pupil abnormalities.
  • Clinically significant uncontrolled glaucoma that could affect visual outcomes.
  • Ocular surface disease or clinically significant dry eye.
  • Anterior segment pathology that could increase surgical risk or compromise lens stability.
  • Diabetic retinopathy.
  • Congenital ocular anomalies.
  • Chronic or recurrent inflammatory eye disease.
  • Active infectious conjunctivitis, keratitis, or uveitis within 30 days before surgery.
  • Pseudoexfoliation syndrome.
  • History of intraocular inflammation/uveitis.
  • Acute ocular, internal, external, or systemic infection.
  • Other ocular or systemic conditions expected to influence visual outcomes, other than age-related macular degeneration.
  • Neurological disorders or other conditions that prevent adequate fixation.
  • Only one functioning eye.
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception where applicable.
  • Participation in another drug or medical-device investigation within the previous 30 days.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    LENTIS® MAX LS-313 MF80

    Device: Intraocular Lens

  • Active comparator
    LENTIS® L-313 monofocal IOL

    Device: Intraocular Lens

Interventions

  • DeviceIntraocular Lens

    Implantation of the investigational devices (IOL)

06

What researchers measure

Primary outcomes

  1. Monocular Corrected Distance Visual Acuity (CDVA) at 4 m

    Time frame: Month 4-6

  2. Monocular Distance-Corrected Near Visual Acuity (DCNVA) at preferred reading distance

    Time frame: Month 4-6

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07915076
Lead sponsor
Teleon Surgical B.V.
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Mar 1, 2030 (estimated)
Completion
Aug 1, 2030 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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