| 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
|
|
|
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
|
|
|
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:
|