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CTRI Number  CTRI/2021/11/037924 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 23/11/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   An observational study to evaluate safety and effectiveness of hydrophilic acrylic intraocular lens. 
Scientific Title of Study   Prospective evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens. 
Trial Acronym  UVEA 809 
Secondary IDs if Any  
Secondary ID  Identifier 
LISA 809 BER-401-20 Version 3.0 date 21.09.2021  Protocol Number 
NCT04907500  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sartaj Singh Grewal 
Designation  Principal Investigator 
Affiliation  Grewal Eye Institute 
Address  SCO-168-169
Sector 9 C
Chandigarh
CHANDIGARH
160009
India 
Phone  9779716169  
Fax    
Email  sartajg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Arora 
Designation  Director 
Affiliation  Clinexel Life Sciences Pvt Ltd 
Address  206
The Corporate Park, Sector 18 Vashi -
Thane
MAHARASHTRA
400705
India 
Phone  9820648395  
Fax    
Email  deepaarora@clinexel.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Arora 
Designation  Director 
Affiliation  Clinexel Life Sciences Pvt. Ltd 
Address  206
The Corporate Park, Sector 18 Vashi
Thane
MAHARASHTRA
400705
India 
Phone  02249723012  
Fax    
Email  deepaarora@clinexel.com  
 
Source of Monetary or Material Support  
Carl Zeiss Meditec AG, Max Dohrn Str 8-10, 10589 Berlin, Germany 
 
Primary Sponsor  
Name  Carl Zeiss Meditec AG 
Address  Max Dohrn Str 8-10 , 10589, Berlin , Germany 
Type of Sponsor  Other [Medical Device Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bulgaria
Czech Republic
India
Poland
Romania  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sartaj Singh Grewal  Grewal Eye Institute  SCO 168-169 Sector 9 C
Chandigarh
CHANDIGARH 		 9779716169

sartajg@gmail.com 
Dr Sri Ganesh  Nehtradhama Superspeciality Eye Hospital  256/14 Kanakapura Main Road Jayanagar 7th Block
Bangalore
KARNATAKA 		 9845129740

phacomaverick@gmail.com 
Dr Krishnaprasad Kudlu  Prasad Netralaya  Behind Alankar Theatre
Udupi
KARNATAKA 		 9845102334
0820-2593325
krishprasadk73@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Indus International Hospital Institute Ethics Committee  Approved 
MAHE Ethics Committee  Submittted/Under Review 
Nethradhama Superspeciality Eye Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients of any gender, aged 18 years or older
2. Patient is planned for aged-related cataract surgery and implantation of the
study IOL into the capsular bag in at least one eye
3. Patient is willing and capable of providing informed consent
4. Patient is willing and capable of complying with visits and procedures as
defined by this protocol 
 
ExclusionCriteria 
Details  1. Preoperative corrected distance visual acuity (CDVA) better than 0.3
logMAR (0.5 decimal)
2. Endothelial cell count of less than 2000/mm2
3. Ocular disorder that could potentially cause a clinically significant future
visual acuity loss
4. Preoperative corneal astigmatism ≥ 1 D or preoperative corneal
astigmatism ≥ 1.5 D, if postoperative corneal astigmatism is not estimated
to be < 1 D.
5. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis,
aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation,
etc.)
6. Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid
marginal degeneration, or irregular astigmatism, clinically significant
corneal membrane dystrophies)
7. Any clinically significant condition that could affect IOL stability (e.g.
zonular dialysis, evident zonular weakness or dehiscence, etc.)
8. Any History of clinically significant retinal pathologies or ocular diagnosis
(e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal
detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus,
microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit
final postoperative visual prognosis
9. Any acute infection (acute ocular disease, external/internal infection,
systemic infection)
10. Any previous intraocular and corneal surgery
11. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular
hypertension treatment
12. Current systemic or ocular pharmacotherapy that effects patients’ vision
13. Current pathology or condition that could be a risk for the patient according
to the investigator opinion
14. Women during pregnancy and/or lactation
15. Patients unable to meet the limitations of the protocol or likely of noncooperation
during the trial
16. Patients whose freedom is impaired by administrative or legal order
17. Subject is enrolled in any other concurrent clinical study, with the exception
of local mandatory governmental registries and observational
studies/registries, that do not affect patients’ vision
Note All eye-related inclusion and exclusion criteria are applicable to the study eye only.
If the non-study eye does not fulfil all criteria, the patient can still be enrolled into
the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Two co-primary effectiveness endpoints assessing the monocular corrected distance visual acuity (CDVA) and the monocular distance-corrected near visual acuity (DCNVA), will be analysed on a binary level (responder analysis). Responders regarding the two endpoints are defined as:
Responder regarding CDVA: The achievement of a monocular CDVA of 0.3 LogMAR or better of the study eye, measured at 400 cm, 6 months after the implantation of the AT LISA 809M/MP.
Responder regarding DCNVA:
The achievement of a monocular DCNVA of 0.3 LogMAR or better of the study eye, measured at 35 cm, 6 months after the implantation of the AT LISA 809M/MP.
 		 6 Months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Monocular corrected distance visual acuity (CDVA)
2.Monocular distance-corrected near visual acuity (DCNVA)
3.Monocular Uncorrected Distance Visual Acuity (UDVA)
4.Monocular Uncorrected Near Visual Acuity (UNVA)
5.Objective and subjective refraction
6.Contrast Sensitivity
7.Subjective Visual Quality

 		 1 Day, 7 days, 30 days, 90 days,180 days and 365 days.
Note: For all available follow up visits upto the 12 months Postoperative visits. No evaluation exploratory only. 
Secondary safety End Points
1. IOL status
2.PCO and Nd:YAG
3.Corneal complications
4.Anterior and posterior segment inflammations
5.Fundus complications
6.Corneal endothelial cell count
7.Intraocular pressure
8.Adverse events and serious adverse events
9.Secondary Surgical Intervention
10.Device deficiency 		 1 Day, 7 days, 30 days, 90 days , 180 days and 365 days.
 
 
Target Sample Size   Total Sample Size="352"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   18/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/06/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a single-arm, prospective, multi-centric study on a long-term CE approved medical device. Patients planned for an aged-related cataract surgery will be contacted and invited to attend a preoperative visit up to 90 days prior to the surgery. The approved intra-ocular lens AT LISA 809M/MP will be implanted in the study eye. Afterwards the patient attends the standard-of-care follow-up visits with cataract surgery and two postoperative visits at 180 days (+/- 7 days) and 365 days (+/-14 days) after the surgery. 
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