Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions
研究概览
简要总结
Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions
时间窗: 1 month postoperatively
Proportion of eyes achieving 20/20 or better uncorrected distance visual acuity under photopic conditions.
Subjective Refractive Error
时间窗: 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
时间窗: 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.
次要结局
- Preloaded System Evaluation Patient Questionnaire(Baseline (preoperative) and 1 month postoperatively)
- Surgical Procedure Assessment(Intraoperative)
研究者
Semih Çakmak
Assistant Professor
Istanbul University