| 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
|
|
|
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
|
|
|
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.
|