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CTRI Number  CTRI/2025/10/096348 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Initial outcomes of Rayner Galaxy IOL  
Scientific Title of Study   Initial outcomes of a new generation, AI designed spiral optic, non-diffractive multifocal IOL 
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 Sri Ganesh  
Designation  Chief Medical Director  
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Sushmiths Sriganesh  
Designation  Chief Research Officer  
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  9448071800  
Fax    
Email  sush.samak@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Sneha G V 
Designation  Phaco & Refractive Fellows 
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  9686946666  
Fax    
Email  snehavasanth2310@gmail.com  
 
Source of Monetary or Material Support  
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore  
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Private hospital/clinic 
 
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 Sneha GV  Nethradhama Super Speciality Eye Hospital   256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 
9686946666

snehavasanth2310@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Comparator Agent  Assessment of contrast sensitivity and defocus curve  postoperative visits at day 1, 2 weeks, 3 months and 12 months 
Intervention  To assess visual outcomes and induced aberrations after implantation of Rayner Galaxy Lens  postoperative visits at day 1, 2 weeks, 3 months and 12 months 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  bilateral implantation of the same IOL
cataractous eyes with no other ocular comorbidity, regular corneal topography and corneal astigmatism
preoperative angle kappa less than 5 degrees and alpha less than 6 degrees
patient desiring spectacle independence and having realistic expectation
availability, willingness and sufficient cognitive awareness to comply with examination procedures,  
 
ExclusionCriteria 
Details  presence of active ocular disease in the operative eye such as chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency,
subjects with any systemic disease that could increase operative risk or confound the outcome, any patient who is taking part in another study involving ocular surgery,s
ignificant irregular corneal astigmatism,
pupil abnormalities – non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic or scotopic conditions.. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess visual outcomes and induced aberrations after implantation of Rayner Galaxy Lens  postoperative visits at day 1, 2 weeks, 3 months and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of contrast sensitivity and defocus curve.  postoperative visits at day 1, 2 weeks, 3 months and 12 months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/10/2025 
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="0"
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  

EXAMINATION PROTOCOL AND STUDY TECHNIQUE

Before the surgery, all patients will undergo a complete ophthalmologic examination including manifest refraction, slit lamp biomicroscopy, noncontact tonometry (Tomey), macular OCT (Optovue, Fremont, USA) and dilated fundus examination. Biometric assessments will be performed using the swept source OCT based optical biometer, IOL Master-700, using the Barrett’s Total Keratometry (TK) formula and Corneal topography (pentacam). All eyes will be targeted at emmetropia.

 

Post-operative assessment will be done on postoperative visits at day 1, 2 weeks, 3 months and 12 months following surgery. Primary clinical tests included manifest refraction (sphere, cylinder and spherical equivalent), uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) measured with ETDRS charts at 60 and 80cm monocularly and binocularly, corrected intermediate visual acuity (CIVA) at 60 and 80 cm, distance corrected near visual acuity (DCNVA) and uncorrected near vision acuity (UNVA) measured with ETDRS chart at 33 and 40 cm monocularly and binocularly. Secondary clinical tests included binocular corrected defocus curves at postoperative 2 weeks, 3 and 12 months of follow-up, rate of development of Posterior Capsular Opacification (PCO), contrast sensitivity (mesopic) using CSV 1000, reading speeds using Salzburg Reading Desk (SRD) at postoperative visit 3 and 12 months follow-up, photic phenomenon by dysphotopsia questionnaire at postoperative 3 and 12 months follow-up, patient satisfaction and spectacle independence questionnaire at postoperative visit 3 and 12 months follow-up and documentation of adverse events at all four postoperative visits.

 

Surgical Procedure

Cataract surgery will be performed by a single experienced  surgeon (S.G.) under topical anaesthesia with 0.5% proparacaine hydrochloride. A clear corneal incision measuring 2.8mm will be made in the temporal limbus then a continuous curvilinear capsulorrhexis measuring 5.0-5.5 mm will be performed (phacoemulsification) or LENSAR/Zeimer machine will be used for FLACS, following which, hydrodissection will be done. The nucleus will then be phacoemulsified. Residual cortex will be removed followed by injection of viscoelastic material (hydroxymethylpropylcellulose 2%) into the anterior chamber. The Rayner galaxy lens will then be injected into the bag and remaining viscoelastic material will be removed. All surgical incisions will be confirmed to be self-sealing before closure.

All patients will be uniformly started on postoperative medications: prednisolone acetate (1%) administered ever four hours in a weekly regression regimen, preservative-free moxifloxacin (0.5%) every four hours for a week, nepafenac (0.1%) three times daily for two weeks and lubricating sodium hyaluronate (0.1%) four times daily for two months

 Postoperative follow-up examinations will be performed by a masked assessor (trained optometrist)  at 1 day, 2 weeks, 3 month and 12 months after surgery. Slit-lamp examination will be performed on the post-op 1 day. The following tests will be performed at all postoperative visits from 2 week onwards:

 


 
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