Active — Not RecruitingNot Applicable

Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System

Turkey (Türkiye)200 participantsStarted 2025-05-10

Plain-language summary

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 range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions

Timeframe: 1 month postoperatively

Subjective Refractive Error

Timeframe: 1 month postoperatively

Overall Clinical Performance of the Preloaded IOL System

Timeframe: 1 month after surgery

Trial details

NCT IDNCT07288086

SponsorIstanbul University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-15

View on ClinicalTrials.gov More Cataract Surgery trials

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.