A Prospective, randomized, controlled, post-marketing clinical study to assess clinical performance and safety of EYECRYL Sert intraocular lens (IOL) versus RAYNER EMV/HOYA Impress IOL in patients with planned age-related cataract surgery.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Distance Corrected Intermediate Monocular Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions (Mean Monocular DCIVA@66cm
研究概览
简要总结
This is a prospective, randomized, controlled, 2 arm comparative, post marketing clinical study in patients withplanned age-related cataract surgery.
Primary Objective: To demonstrate that EYECRYL Sert exhibits non inferiority for Distance Corrected Intermediate Visual Acuity (DCIVA) over TECNIS EyhanceTM.
Secondary Objective: To demonstrate that EYECRYL Sert has at least 50% eyes achieving photopic monocular DCIVA 0.2 logMAR or better @ 66cm.
| 1)****Visual Acuity→ Visual Acuity (VA) is measured in logMAR. logMAR |
| is the "logarithm of the minimum angle of resolution". A lower logMAR |
| value indicates better visual acuity. Visual acuity measured by ETDRS Charts |
a. Uncorrected Distance Visual Acuity (UDVA) → [Time frame: (Monocular: Pre-operative, Post-operative: 1-2 days, 7-14 days, 30-60 days, 120-180 days 330-420 days) & (Binocular: Post – operative 30-60 days, 120-180 days & 330-420 days)]
It will be measured Original Series SLOAN Letter ETDRS (Set of 3) (4 Meter) (Precision Vision, SKU : 2100B1) in logMAR.
b. Corrected Distance Visual Acuity (CDVA) → [(Time frame: Monocular: Pre-operative, Post-operative: 7-14 days, 30-60 days, 120-180 days, 330-420 days) & (Binocular: Post – operative 120-180 days & 330-420 days)]
It will be measured Original Series SLOAN Letter ETDRS (Set of 3) (4 Meter) (Precision Vision, SKU : 2100B1) in logMAR
c. Uncorrected Intermediate Visual Acuity (UCIVA) → [Time frame: (Monocular: Post-operative: 30-60 days, 120-180 days, 330-420 days) & (Binocular: Post – operative, 120-180 days & 330-420 days)]
It will be measured by SLOAN ETDRS Intermediate Vision Chart (66cm) (Precision Vision, SKU: 2106-66) in logMAR.
d. Distance-Corrected Intermediate Visual Acuity at 66 cm → (DCIVA) [Time frame: (Monocular: Post-operative: 30-60 days, 120-180 days and 330-420 days) & (Binocular: Post – operative 120-180 days & 330-420 days)].
It will be measured by SLOAN ETDRS Intermediate Vision Chart (66cm) (Precision Vision, SKU: 2106-66) in logMAR.
e. Corrected Near Visual Acuity (CNVA) at 40 cm → [Time frame: (Monocular: Pre-operative, Post-operative: 30-60 days, 120-180 days, 330-420 days) & (Binocular: Post – operative 120-180 days & 330-420 days)]
It will be measured by SLOAN ETDRS Near Vision Chart – 40cm (Precision Vision, SKU : 2106) in logMAR.
f. Uncorrected Near Visual Acuity (UCNVA) at 40 cm → [Time frame: (Monocular: Pre-operative, Post-operative: 30-60 days, 120-180 days, 330-420 days) & (Binocular: Post – operative 120-180 days & 330-420 days)].
It will be measured by SLOAN ETDRS Near Vision Chart – 40cm (Precision Vision, SKU : 2106) in logMAR.
**g.**Distance Corrected Near Visual Acuity (DCNVA) at 40 cm → [Time frame: (Monocular: Pre-operative, Post-operative: 30-60 days, 120-180 days, 330-420 days) & (Binocular: Post – operative 120-180 days & 330-420 days)]
It will be measured by SLOAN ETDRS Near Vision Chart – 40cm ) (Precision Vision, SKU : 2106) in logMAR.
2) Monocular low contrast intermediate visual acuity at 66 cm:
• Distance-Corrected Intermediate Visual Acuity (Low contrast 10%) (DCIVA) → [Time frame: Post-operative: 120-180 days]
It will be measured Mixed Contrast European Wide Near Vision Card 66cm (Precision Vision, SKU: 2831) in logMAR under photopic condition.
• Best-Corrected Intermediate Visual Acuity (Low contrast 10%) → [Time frame: Post-operative: 120-180 days].
It will be measured by Mixed Contrast European Wide Near Vision Card 66cm (Precision Vision, SKU: 2831) in logMAR under photopic condition.
3) Manifest Refraction [Time frame: Pre-operative, Postoperative: 7-14 days, 30-60 days, 120-180 days and 330-420 days]
It will be measured bystandard trial lens set or phoropter (subjective refraction).
**4)**Slit lamp Examinations:
**a.**Aqueous Cells & Flare [Time Frame: Pre-operative, Postoperative: 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day] by SUN *(*standardization of uveitis nomenclature)
**b.**Corneal Edema [Time Frame: Pre-operative, Post-operative: 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day] by SUN
**c.**Signs of Inflammation [Time Frame: Pre-operative, Postoperative: 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day]
**d.**Pupillary Block [Time Frame: Pre-operative, Post-operative: 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day]
**e.**Status of Anterior and Posterior Capsule [Time Frame: Pre-operative]
**f.**Fundus Examination with Dilated Pupil [Time Frame: Preoperative, Post-operative: 120-180 days and 330-420 day]
5) Keratometry [Time Frame: Pre-Operative, day 1-2, day 7-14 days, 30-60 days, 120-180 days and 330-420 days postoperative]
Measured in Diopters by Pentacam
6) Corneal Thickness [Time Frame: Pre-Operative]
It will be measured by Pentacam.
7) Axial Length [Time frame: Pre-operative]
It will be measured by Optic Biometry (as per the trial site set-up)
8) Anterior Chamber Depth [Time frame: Pre-operative]
It will be measured by Pentacam from endothelium.
9) Gonioscopy [Time frame: Pre-operative]
It will be measured with gonio lens through slit lamp.
10) Intraocular Pressure [Time frame: Pre-operative, Postoperative: 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 days]
Intraocular pressure as measured by Goldman applanation tonometer.
11) Pupil Size (under Photopic condition and mesopic condition) → [Time Frame: Preoperative, Post – operative: 120-180 days and 330-420 days]
It will be measured by Pentacam
12) IOL Tilt [Time frame: Post-operative: 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 days]
It will be measured by Pentacam & Scheimpflugcamera Imaging
13) IOL Decentration [Time frame: Post-operative: 1-2 days, 714 days, 30-60 days, 120-180 days and 330-420 days]
It will be measured by Pentacam & Scheimpflugcamera Imaging
14) Retinal detachment: Time frame: Pre-operative, 1-2days, 7-14 days, 30-60 days, 120-180 days, 330-420 days, 630-780 days and 990-1140 days post operatively.
15) Patient Questionnaire [Quality of Vision, QOV] [Time frame: Post operative 30-60 days, 120-180 days and 330-420 days]
This will be carried out using the “Patient Questionnaire – Quality of Visionâ€
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified McAlinden Survey will be used. The maximum score for each question is 100. This assessment is done binocularly.
16) Far Contrast Sensitivity [Time frame: Post-operative: 120-180 days, 330-420 days]
It will be measured in each arm using a backlit sine wave grating chart system (CSV1000-HGT, VectorVision, Greenville, OH).
• Monocular mesopic contrast sensitivity (with and without glare)
• Monocular photopic contrast sensitivity (with and without glare)
17) Defocus Curve Test (photopic) (Monocular and Binocular) [Time frame: Post-operative: 30-60 days, 120-180 days and 330-420 days]
The zero reference on the x-axis is controlled across patients by correcting for the best possible distance acuity. Using 0.50-D increments, the defocus curve measures a patient’s binocular / uniocular visual acuity often from +1.00 D to -4.00 D. In doing so, the resulting acuity that is measured can be used to simulate what the patient’s visual acuity would be at different distances.
18) Posterior capsule opacification (PCO) Assessment [Time frame: Post-operative: 30-60 days, 120-180 days and 330-420 days]
PCO will be measured by Slit Lamp Examination. This will illustrate the various grades for both fibrosis bands and pearls. Those following grades were given;
0 = none,
1 = minimal PCO without reduced red reflex, also no pearls at all or pearls not to the IOL edge.
2 = mild PCO reducing the red reflex, Elschnig pearls to the IOL edge.
3
moderate fibrosis or Elschnig pearls inside IOL edge but with clear visualaxis.
4
severe fibrosis
19) Adverse Events and Serious Events Monitoring → [Time frame: Intra-operative, Post-operative: 1 day, 7 days, 30-60 days, 120-180 days and 330-420 days]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •(1) Patients having cataract (2) Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator’s medical opinion.
排除标准
- •(1) Systemic disease that could increase the operative risk or confound the outcome; (2) instability of keratometry or biometry measurements; and (3) irregular astigmatism.
- •(4) Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)); (5) Ocular condition that may predispose for future complications (6) Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject; (7) Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes; (8) Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse (9) Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens; (10) If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment; (11) Concurrent participation in another drug or device study.
结局指标
主要结局
1. Distance Corrected Intermediate Monocular Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions (Mean Monocular DCIVA@66cm
时间窗: 180 days
次要结局
- 1. In the study group, 50% of eyes achieving photopic monocular Distance Corrected Intermediate Visual Acuity (DCIVA) 0.2 logMAR or better @66 cm(120-180 days)
研究者
Dr Namrata Sharma
All India Institute of Medical Sciences