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CTRI Number  CTRI/2024/06/068297 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the visual outcomes between EYECRYL lens and RAYNER EMV/HOYA IOL in cataract surgery patients 
Scientific Title of Study   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. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata Sharma  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 494, fourth floor, Department of ophthalmology, Dr RP Centre for ophthalmic sciences Ansari Nagar, New Delhi-110029
Room no 494, fourth floor, Department of ophthalmology, Dr RP Centre for ophthalmic sciences Ansari Nagar, New Delhi-110029
South
DELHI
110029
India 
Phone    
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namrata Sharma 
Designation  Professor  
Affiliation  AIIMS, New Delhi 
Address  Room no 494, Fourth floor, Dr R.P.Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.

South
DELHI
110029
India 
Phone  9810856988  
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Namrata Sharma 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 494, Fourth floor, Dr R.P.Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.

South
DELHI
110029
India 
Phone  9810856988  
Fax    
Email  namrata.sharma@gmail.com  
 
Source of Monetary or Material Support  
BIOTECH VISION CARE PVT. LTD Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India  
 
Primary Sponsor  
Name  BIOTECH VISION CARE PVT LTD 
Address  Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Sharma  AIIMS, New Delhi  Room no 45, ground floor, Dr R.P.Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi
South
DELHI 		 9868398412

namrata.sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, aiims  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EYECRYL Sert intraocular lens Intraocular Lens   Preloaded monofocal Hydrophobic Aspheric EDOF (Extended depth of focus) lens will be placed during cataract surgery and patients will be followed for 420 days 
Comparator Agent  RAYNER EMV/HOYA Impress IOL  Intraocular lens will be placed during cataract surgery and patients will be followed for 420 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  (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

 
 
ExclusionCriteria 
Details  (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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Distance Corrected Intermediate Monocular Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions (Mean Monocular DCIVA@66cm   180 days 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective, randomized, controlled, 2 arm comparative, post marketing clinical study in patients with planned 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 by standard 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 & Scheimpflug camera 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 & Scheimpflug camera 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 Vision”

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 visual axis. 

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]

 
 
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