Clinical Trials in Turkey / NCT07288086
Active, not recruiting
Not applicable
Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System
NCT07288086 · tracked via the Priya Life Science Turkey tracker
Condition(s) studied
Cataract SurgeryIntraocular Lens
Investigational drug(s) / intervention(s)
Preloaded intraocular lens system
Preloaded intraocular lens system: This intervention uses a preloaded IOL delivery system, which allows for a single-use, sterile implantation during standard phacoemulsification cataract surgery. Unlike standard manually loaded IOLs, this system reduces preparation time and minimizes handling of the lens, potentially improving surgical efficiency and maintaining lens sterility.
Study summary
Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery
Eligibility
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 significant atopic disease, diabetes, or other systemic or ocular conditions).
Participation in any investigational drug or device study within 30 days prior to study start, or ongoing participation in another study.
Primary outcome measure(s)
- Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions — 1 month postoperatively
Proportion of eyes achieving 20/20 or better uncorrected distance visual acuity under photopic conditions. - Subjective Refractive Error — 1 month postoperatively
Eyes with a postoperative refractive error within ±0.50 diopters of the intended target. - Overall Clinical Performance of the Preloaded IOL System — 1 month after surgery
Surgeon-rated assessment of the general clinical performance of the preloaded system by The ENOVA PGF3 Questionnaire. This questionnaire is a 14-item, study-specific, non-validated survey developed to evaluate surgeons' experience with an intraocular lens (IOL) preloaded delivery system. Eleven items are rated on a 5-point Likert scale with the following scoring structure: 1. = Low 2. = Below Expectation 3. = Meets Expectation 4. = Above Expectation 5. = Outstanding Performance Some additional items are Yes/No questions and do not contribute to the numerical total score. The total numerical score is calculated by summing the 11 Likert-scaled items. Total score range: 11 to 55, with higher scores indicating better performance and more favorable user experience.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Istanbul University Istanbul Medical Faculty Ophthalmology Department | Istanbul | Fatih |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07288086 on ClinicalTrials.gov ↗ ← All trials in Turkey