| CTRI Number |
CTRI/2025/08/092621 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To assess clinical performance and safety of EDOF Hydrophilic IOL in patients who require EDOF IOL implantation during routine cataract Surgery. |
|
Scientific Title of Study
|
Prospective, Controlled, Randomized, Masked Unilateral or Bilateral implantation, Single Centre, Clinical investigation study to evaluate Safety and Performance of EDOF (Extended Depth of Focus) IOL (Omni Lens Pvt Ltd) in patients who require EDOF IOL implantation during routine cataract Surgery. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OLPL-EDOF-CIP-25-01 Version 01 Dated 21-Apr-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday R Gajiwala |
| Designation |
Superintendant |
| Affiliation |
Divyajyoti Trust- Tejas Eye Hospital |
| Address |
Divyajyoti Trust-Tejas Eye Hospital,
Research Office, C block
Room no C-28, Ground Floor,
At and PO : Amalsadi
Ta- Mandvi
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
02623221090 |
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday R Gajiwala |
| Designation |
Superintendant |
| Affiliation |
Divyajyoti Trust- Tejas Eye Hospital |
| Address |
Divyajyoti Trust-Tejas Eye Hospital,
Research Office, C block
Room no C-28, Ground Floor,
At and PO : Amalsadi
Ta- Mandvi
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
02623221090 |
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday R Gajiwala |
| Designation |
Superintendant |
| Affiliation |
Divyajyoti Trust- Tejas Eye Hospital |
| Address |
Divyajyoti Trust-Tejas Eye Hospital,
Research Office, C block
Room no C-28, Ground Floor,
At and PO : Amalsadi
Ta- Mandvi
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
02623221090 |
| Email |
divyajyoti.icare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Omni Lens Pvt. Ltd.
eg. Office: 5, Samruddhi, Opp. Sakar III, Navarangpura, Ahmedabad-380014, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Omni Lens Pvt Ltd |
| Address |
Reg. Office: 5, Samruddhi, Opp. Sakar III, Navarangpura, Ahmedabad-380014, Gujarat, India |
| Type of Sponsor |
Other [Manufacturer of IOLs(Medical Devices)] |
|
|
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 Uday R Gajiwala |
Divyajyoti Trust-Tejas Eye Hospital |
Research Office, C-block
Room no C-28, Ground Floor,
At and PO: Amalsadi
Ta-Mandvi
Pin-394163
Surat
GUJARAT |
02623221180
02623221090
divyajyoti.icare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Divyajyoti Trust-Tejas Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z961||Presence of intraocular lens, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EDOF Hydrophilic Acrylic Foldable IOL(Omni Lens Pvt. Ltd.) |
Route of Administration : Intraocular, Duration of Therapy : One Time insertion, Dose : NA , Frequency : NA |
| Comparator Agent |
NA |
NONE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Cataract (Unilateral/Bilateral)
2.Calculated EDOF IOL power is within the range of the Study device i.e. 8 to 30 D (+3.00D)
3.The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent.
4.Clear intraocular media other than cataract
5.The patient is willing to comply with protocol specified follow-up evaluations.
#If any of the above criteria is answered ‘No’, the subject may not be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
1. Previous intraocular or corneal surgery
2. Traumatic cataract and/or existing inflammation
3. Pregnancy or lactation
4. Concurrent participation in another drug or device investigation
5. At the time of surgery conditions such as zonular instability, need for iris manipulation, capsular fibrosis or other opacity and inability to fixate EDOF IOL in desired position.
6. Instability of keratometry or biometry measurements
7. Irregular astigmatism
8. History of intraocular Inflammation
9. Subjects who may be reasonably expected to require secondary surgical intervention at any time during the investigation (other than YAG capsulotomy).
10. Gonioscopy Abnormalities
11. More than 1 D of pre-operative corneal astigmatism
12. Minor under the age of 18
13. Those who are participating in other clinical trials of drugs or medical devices.
# If any of the above criteria is answered ‘YES’, the subject may not be enrolled in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Best-Corrected distance visual acuity(CDVA)
2. Distance -corrected intermediate visual acuity(DCIVA)
3. Distance-corrected near visual acuity(DCNVA) |
1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks)
2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks]
3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Depth of focus curve Test
2. Adverse event rates
3. Far Contrast Sensitivity
4. Sign of Inflammation |
1. Depth of focus curve Test (after 18 weeks)
2. Adverse event rates (at baseline, 1 day,1week, 4 weeks & 18 weeks)
3. Far Contrast Sensitivity (after 18 weeks)
4. Sign of Inflammation (1 day, 1 week, 4 weeks & 18 weeks)
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
20/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Prospective, Controlled, Randomized, Masked Unilateral or Bilateral Implantation, Single Centre Clinical Investigational study of EDOF Hydrophilic Acrylic Foldable IOL (Omni Lens Pvt.Ltd.) in patients who require EDOF Implantation during routine cataract surgery. |