Cataract Surgery, Intraocular Lens
Conditions
Keywords
cataract surgery, intraocular lens, preloaded intraocular lens, Enova
Brief summary
Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery
Detailed description
In this prospective and single-center clinical study, the safety and efficacy of the Enova PGF3 intraocular lens (IOL) and cartridge injector system will be evaluated. The Enova PGF3 cartridge injector system is designed to be used in cataract surgeries. Cataract patients aged 40 years and older, both male and female, without any serious ocular disease other than cataracts, will undergo IOL implantation following cataract surgery. It is planned to perform a total of 200 implantations with either unilateral or bilateral implantation of the participants' eyes. Postoperative visual acuity, refraction, patient satisfaction, and adverse events will be monitored during follow-up visits at day 1, week 1, and month 1. The primary objectives of the study are to achieve an uncorrected distance visual acuity of 20/20 or better, and to maintain an error and complication rate related to the preloaded system below 7.5%. Secondary objectives include evaluating patient satisfaction and assessing whether surgeons find the preloaded system easy to use and if it meets their expectations. The primary endpoints are refractive stability within ±0.50 D, uncorrected distance visual acuity of 20/20 or better, and a general clinical performance rating of the preloaded system with a score of 95% or higher. Secondary endpoints include the duration of surgery, accuracy of lens positioning, surgical complications, surgeon-reported ease of use, and patient satisfaction survey results meeting expectations. As a safety parameter, adverse events reported in postoperative surgical reports will be evaluated.
Interventions
DEVICEPreloaded 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.
Sponsors
Istanbul University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preloaded System Evaluation Patient Questionnaire | Baseline (preoperative) and 1 month postoperatively | Patient-reported outcomes assessing whether expectations for visual improvement and overall satisfaction were met.The questionnaire consists of 14 items assessing a patient's self-reported difficulty in performing vision-related daily activities. Each activity is rated using a 0-4 scale, where: 4 = No difficulty 3 = Mild difficulty 2 = Moderate difficulty 1 = Severe difficulty 0 = Unable to perform the activity The total score is calculated by summing responses across all 14 items. Total possible score range: 0 to 56 Higher scores indicate better visual function and less activity limitation. Lower scores indicate worse visual function. |
| Surgical Procedure Assessment | Intraoperative | Surgeon-reported ease of lens implantation and accuracy of lens placement, evaluating whether expectations for procedural handling were met.The surgeon notes, during the operative visit, the location of the incision, the size of the incision, whether the implantation system is compatible with the wound site, how many seconds the implantation time is shortened, and whether there were any issues with the unfolding of the intraocular lens or its placement into the capsular bag. |
Countries
Turkey (Türkiye)
Outcome results
None listed