Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* Adults of either sex.
Age 40 years or older.
Willing and able to provide written informed consent and comply with planned study visits and procedures.
Healthy ocular status, with no ocular pathology other than cataract and mild refractive error.
Potential visual acuity of 20/32 (0.2 logMAR) or better in both eyes.
Presence of regular corneal astigmatism suitable for treatment with the study device.
Candidates for uncomplicated cataract surgery using the study device.
Exclusion Criteria:
* Irregular corneal astigmatism (e.g., keratoconus).
Corneal pathology (e.g., scar, dystrophy, pterygium, moderate to severe dry eye).
Monocular conditions (e.g., amblyopia).
Previous corneal surgery, including radial keratotomy, corneal refractive surgery, corneal transplantation, DSAEK, or lamellar keratoplasty.
Previous anterior or posterior segment surgery (e.g., vitrectomy, laser iridotomy).
Diabetic retinopathy.
Macular pathology (e.g., age-related macular degeneration \[ARMD\], epiretinal membrane \[ERM\]).
History of retinal detachment.
Surgical complications that may affect study outcomes, such as:
Decentration due to capsulorhexis issues
Improper lens placement
Inadequate or missing postoperative capsular support
Posterior capsular rupture
Vitreous loss
Iris damage (tear, rupture, etc.)
Acute or chronic ocular diseases known to affect visual acuity or study outcomes (e.g., immunosuppressed state, connective tissue disease, clinically sign…