FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/102183 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Comparison of Visual Results and Lens Stability of Extended Depth of Focus Toric Intraocular Lenses with Two Different Sizes 
Scientific Title of Study   Clinical Outcomes and Rotational Stability of EDOF Toric lens using two Different sized IOLs 
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

Bangalore
KARNATAKA
560070
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  DrSuchetha 
Designation  Phaco & refractive fellow 
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

Bangalore
KARNATAKA
560070
India 
Phone  8129193309  
Fax    
Email  Suchithrasuzi007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSuchetha 
Designation  Phaco & refractive fellow 
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


KARNATAKA
560070
India 
Phone  8129193309  
Fax    
Email  Suchithrasuzi007@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  Nethradhama Super Speciality Eye Hospital 
Address  256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore  
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 
DrSuchetha   Nethradhama Super Speciality Eye Hospital   256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore
Bangalore
KARNATAKA 
8129193309

Suchithrasuzi007@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: H258||Other age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1. To assess the visual outcomes (uncorrected and corrected distance, intermediate, and near visual acuity) with the two different lens diameters.  2. To evaluate refractive predictability and residual astigmatism following implantation. 
Intervention  To compare the postoperative rotational stability of toric EDOF intraocular lenses implanted in pseudophakic eyes using two different lens diameters selected according to the patient’s IOL Diopteric power.  Pre operatively all patients will undergo visual acuity assessment- distance, intermediate (80cm, 60cm, 40cm), near (33cm) (ETDRS chart), intra ocular pressure measurement (Topcon NCT?), Slit lamp examination, keratometry, white to white, A scan (IOLMaster 700, Zeiss Meditec., Germany), Schiempflug- based corneal topography (Pentacam, Oculus), specular microscopy (Tomey, Keeler?), and Fundus examination. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  2. Patients undergoing cataract surgery for both eyes.
3. Eyes planned for pseudophakic implantation of a toric EDOF IOL.
Preoperative corneal regular astigmatism less than 0.75 D and less than 3.50 D suitable for toric correction.
WTW measurement taken from IOLMaster 700 optical biometer.
Axial length between 22.0 mm and 26.0 mm.
Clear cornea and normal anterior segment anatomy.
Ability to attend follow-up visits for at least 3 months postoperatively.
 
 
ExclusionCriteria 
Details  1. History of other ocular surgeries in the study eye.
2. Irregular corneal astigmatism or corneal pathology.
3. Glaucoma with uncontrolled intraocular pressure or optic nerve damage.
4. Retinal pathology affecting visual potential.
5. Anterior segment anomalies along with zonular instability, capsular bag abnormalities, or pseudoexfoliation that may interfere with IOL implantation or rotation assessment.
6. Pupillary abnormalities.
7. Intraoperative complications (e.g., posterior capsular rupture, vitreous loss).
8. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative rotational stability of toric EDOF intraocular lenses implanted in pseudophakic eyes using two different lens diameters selected according to the patient’s IOL Diopteric power.  1 day, day 15, and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the visual outcomes (uncorrected and corrected distance, intermediate, and near visual acuity) with the two different lens diameters.
2. To evaluate refractive predictability and residual astigmatism following implantation.
3. To determine patient satisfaction and visual quality, including the presence of photic phenomena (glare, halos, starbursts).
4. To analyze correlations between WTW measurements, axial length, and IOL Diopteric power.
5. To assess any IOL-related complications (decentration, tilt, or need for repositioning).
 
1 day, day 15, and 3 months 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   12/02/2026 
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  

This prospective interventional single center study will be approved by the Institutional Ethics Committee of Nethradhama Super Speciality Eye Hospital Bangalore and will be conducted in accordance with the tenets of the Declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.

Preoperatively all patients will undergo a detailed ophthalmic evaluation including assessment of visual acuity for distance intermediate at 80 cm 60 cm and 40 cm and near at 33 cm using the ETDRS chart. Intraocular pressure measurement will be performed using non contact tonometry. Slit lamp examination keratometry white to white measurement A scan biometry using IOLMaster 700 Zeiss Meditec Germany Scheimpflug based corneal topography using Pentacam Oculus specular microscopy using Tomey Keeler and dilated fundus examination will be carried out for all patients.

Intraocular lens selection will be done using toric extended depth of focus intraocular lenses of two different sizes provided by the manufacturer as per study protocol.

All surgeries will be performed under topical anesthesia by an experienced surgeon. Patients undergoing femtosecond laser assisted cataract surgery will undergo capsulotomy using a femtosecond laser platform. A temporal clear corneal incision of 2.8 mm will be made followed by a continuous curvilinear capsulorhexis of approximately 5.0 to 5.5 mm ensuring adequate overlap of the intraocular lens optic. Standard hydrodissection and hydrodelineation will be performed and the crystalline lens will be removed using routine phacoemulsification techniques. The selected toric extended depth of focus intraocular lens will be implanted into the capsular bag and initially rotated close to the intended axis. After complete removal of viscoelastic material from the anterior chamber and behind the lens the intraocular lens will be precisely aligned with the marked axis using the Callisto system Zeiss Meditec Germany. Wound hydration will be performed to ensure a watertight closure.

Postoperatively all patients will receive standard topical antibiotic therapy with moxifloxacin topical steroids with prednisolone acetate one percent and a non steroidal anti inflammatory drug nepafenac. Follow up visits will be scheduled on postoperative day one day fifteen and three months.

Postoperative evaluation will include monocular and binocular visual acuity assessment for distance intermediate at 80 cm 60 cm and 40 cm and near at 33 cm using the ETDRS chart refraction and monocular and binocular defocus curves ranging from plus three diopters to minus three diopters. Slit lamp examination will be performed on day one day fifteen and three months after surgery. Dilated fundus examination and slit lamp photography to assess intraocular lens rotational stability will be conducted on day fifteen and three months. Patient satisfaction questionnaire will be administered on day fifteen.

Any complications protocol deviations or serious adverse events will be reported to the Institutional Ethics Committee within forty eight hours of occurrence.


 
Close