| CTRI Number |
CTRI/2025/04/083817 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical outcomes after bilateral implantation of an Advanced Monofocal Intraocular Lens |
|
Scientific Title of Study
|
Visual and functional outcomes after bilateral implantation of an Enhanced monofocal Intraocular Lens targeted for Mini-Monovision |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUPRIYA SRIGANESH |
| Designation |
MS Ophthalmology, FPRS (Fellow in Phacorefractive Surgery) |
| Affiliation |
Nethradhama Superspeciality Eye Hopsital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India
Bangalore
KARNATAKA
560070
India |
| Phone |
8951027740 |
| Fax |
|
| Email |
dr.supriyasriganesh@nethradhama.org |
|
Details of Contact Person
Scientific Query
|
| Name |
NISHIKA JAIN |
| Designation |
MBBS, MS (Ophthalmology) |
| Affiliation |
Nethradhama Superspeciality Eye Hopsital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India
Bangalore
KARNATAKA
560070
India |
| Phone |
9712901438 |
| Fax |
|
| Email |
nishikajain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKANKSHA SHARMA |
| Designation |
MBBS, MS (Ophthalmology) |
| Affiliation |
Nethradhama Superspeciality Eye Hopsital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India
Bangalore
KARNATAKA
560070
India |
| Phone |
09834843157 |
| Fax |
|
| Email |
akankshas1318@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Super Speciality Eye Hospital, #256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| AKANKSHA SHARMA |
Nethradhama Superspeciality Eye Hopsital |
Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India
Bangalore
KARNATAKA |
09834843157
akankshas1318@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Phacoemulsification with bilateral implantation of an Extended Depth Of Focus intraocular lens |
The Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) is an enhanced monofocal IOL made from glistening-free hydrophobic acrylate. Its aspheric optic design extends the depth of field, particularly improving vision in the intermediate range. Mini-monovision is a vision correction technique commonly used in cataract and refractive surgeries to reduce dependency on glasses, particularly for patients who want better near and intermediate vision without compromising distance vision. In this approach, one eye (usually the dominant eye) is optimized for distance vision, while the other eye is set for intermediate or near vision by using different intraocular lenses (IOLs) or modifying the prescription. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts, Posterior subcapsular cataract
2. Age >35 years
3. Corneal astigmatism less than 0.75D
4. IOL power between +10D to +30D
5. In the bag IOL implantation
|
|
| ExclusionCriteria |
| Details |
1. Eyes with corneal astigmatism >0.75 D
2. Hypermature/morgagnian/intumescent and brunescent cataracts >NS 4
3. Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts <1500cells/ mm2
4. Pupillary abnormalities
5. History of glaucoma or intraocular inflammation
6. Macular disease or retinopathy, neuro-ophthalmic diseases, active infections, previous ocular surgery of any kind, any other ocular pathology.
7. Intraoperative or postoperative complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uncorrected Distant Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA) at 40, 60, 80cm and Uncorrected Near Visual Acuity |
Post operative Day 1, 2 weeks and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Contrast sensitivity, Objective scatter index, Defocus curves & Aberrations |
Post operative Day 1, 2 weeks & 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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 Yet Recruiting |
| 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 study aims to assess the clinical outcomes, the level of spectacle independence, and patient satisfaction after bilateral implantation of an enhanced depth of focus (EDOF) IOL-Hoya Impress EDOF targeted for mini-monovision. The Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) is an enhanced monofocal IOL made from glistening-free hydrophobic acrylate. Its aspheric optic design extends the depth of field, particularly improving vision in the intermediate range. Mini-monovision is a vision correction technique commonly used in cataract and refractive surgeries to reduce dependency on glasses, particularly for patients who want better near and intermediate vision without compromising distance vision. In this approach, one eye (usually the dominant eye) is optimized for distance vision, while the other eye is set for intermediate or near vision by using different intraocular lenses (IOLs) or modifying the prescription. |