NCT07915076Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 4.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 35 (tervezett)
- Első benyújtás
- 2026. okt. 19.
- Kezdés
- 2027. febr. 1.
- Elsődleges befejezés
- 2030. márc. 1.
- Fő szponzor
- Teleon Surgical B.V.
- Betegségek
- Időskori makuladegeneráció
- NCT-szám
- NCT07915076
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 35
- 2027. febr. 1. és az elsődleges befejezés (2030. márc. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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.
Más betegség
- 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.
Életkor
- 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.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.