CataractNCT07915076
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.
A study testing Intraocular Lens in people with Cataract and AMD - Age-Related Macular Degeneration, run by Teleon Surgical B.V..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cataract, AMD - Age-Related Macular Degeneration
- What is being tested?
- Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
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:
Read more
- 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?
- 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.
- Conditions
- Cataract, AMD - Age-Related Macular Degeneration
- Being tested
- Intraocular Lens
- Medical subject headings
- Cataract, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular LensDevice
Implantation of the investigational devices (IOL)
| Study group | Role | What they receive |
|---|---|---|
| LENTIS® MAX LS-313 MF80 | Experimental | Not described Receives: Device: Intraocular Lens |
| LENTIS® L-313 monofocal IOL | Active comparator | Not described Receives: Device: Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Corrected Distance Visual Acuity (CDVA) at 4 m
Measured: Month 4-6
Monocular Distance-Corrected Near Visual Acuity (DCNVA) at preferred reading distance
Measured: Month 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teleon Surgical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915076
- Sponsor's protocol ID
- 2026_SIT_MF80
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07915076
- Acronym / sponsor ID
- 2026_SIT_MF80
- Conditions
- Cataract, AMD - Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Teleon Surgical B.V.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LENTIS® MAX LS-313 MF80 | Experimental | Device: Intraocular Lens |
| LENTIS® L-313 monofocal IOL | Active comparator | Device: Intraocular Lens |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular LensImplantation of the investigational devices (IOL) | Device | LENTIS® L-313 monofocal IOL, LENTIS® MAX LS-313 MF80 |
Primary outcome
Monocular Corrected Distance Visual Acuity (CDVA) at 4 m
Time frame: Month 4-6
Monocular Distance-Corrected Near Visual Acuity (DCNVA) at preferred reading distance
Time frame: Month 4-6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular Lens in people with Cataract and AMD - Age-Related Macular Degeneration, run by Teleon Surgical B.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Corrected Distance Visual Acuity (CDVA) at 4 m (time frame: Month 4-6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.