| CTRI Number |
CTRI/2025/11/097387 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing vision clarity and daily visual comfort after cataract surgery using two types of trifocal eye lenses |
|
Scientific Title of Study
|
Comparison of visual performance and quality of vision between two trifocal intraocular lenses randomized clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Tomar |
| Designation |
Pg Student |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Department of ophthalmology command hospital eastern command
New Alipore, Kolkata, West Bengal ,India
Kolkata
WEST BENGAL
700053
India |
| Phone |
6397754136 |
| Fax |
|
| Email |
Tomarprashant337@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Department of Ophthalmology, Command Hospital (Eastern Command)
New Alipore, Kolkata, West Bengal ,India
Kolkata
WEST BENGAL
700027
India |
| Phone |
9602906343 |
| Fax |
|
| Email |
Santo21051977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Department of Ophthalmology, Command Hospital (Eastern Command), New Alipore, Kolkata, West Bengal
Department of Ophthalmology, Command Hospital (Eastern Command), New Alipore, Kolkata, West Bengal
Kolkata
WEST BENGAL
700027
India |
| Phone |
9602906343 |
| Fax |
|
| Email |
Santo21051977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology,
Command Hospital (Eastern Command),
Alipore, Kolkata – 700027,
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Prashant Tomar |
| Address |
Department of ophthalmology command hospital eastern command Kolkata |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prashant Tomar |
Command Hospital Eastern Command Kolkata |
Department of Ophthalmology, Command Hospital (Eastern Command), Alipore, Kolkata – 700027, West Bengal, India
Kolkata
WEST BENGAL |
6397754136
TOMARPRASHANT337@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee command hospital eastern command Alipore Kolkata -27 |
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 |
| Intervention |
BVI PhysIOL Trifocal Intraocular Lens implantation
|
Patients undergoing phacoemulsification for age-related cataract will receive BVI PhysIOL trifocal intraocular lens implantation. Surgery will be performed under aseptic precautions using standard phacoemulsification technique by the same surgeon. Follow-up will be done at 1 week and 1 month postoperatively. Outcome measures include uncorrected distance, intermediate, and near visual acuity, assessment of glare and halos, and quality of vision questionnaire (Rasch score).”
|
| Comparator Agent |
Tecnis Synergy Trifocal Intraocular Lens implantation
|
Patients undergoing phacoemulsification for age-related cataract will receive Tecnis Synergy trifocal intraocular lens implantation. The same surgical technique, surgeon, and postoperative follow-up protocol will be used as in the intervention group. Visual outcomes, glare, halos, and quality of vision will be assessed and compared.”
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged greater than 18 years with age-related cataract.
2. Willing for trifocal intraocular lens implantation.
3. Desire for spectacle independence at all distances.
4. Willing to participate in the study and provide written informed consent.
5. Able to comply with postoperative follow-up schedule.
|
|
| ExclusionCriteria |
| Details |
1. History of previous ocular surgery or trauma.
2. Presence of ocular comorbidities such as glaucoma, diabetic retinopathy, or macular degeneration.
3. Irregular corneal astigmatism or keratoconus.
4. Corneal opacity or any other condition affecting visualization of intraocular structures.
5. Systemic diseases that may affect vision or healing, such as uncontrolled diabetes mellitus or multiple sclerosis.
6. Intraoperative complications such as posterior capsular rupture or zonular weakness.
7. Psychiatric illness or cognitive impairment that affects the ability to complete subjective questionnaires.
8. Patients with unrealistic expectations regarding postoperative visual outcomes.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses.
|
Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of glare & halos using NEI near vision subscale — at 4 weeks postoperatively.
2. Quality of vision assessment using Rasch-scored Quality of Vision questionnaire — at 4 weeks postoperatively.
3. Patient satisfaction with visual performance — at 4 weeks postoperatively.
|
4 weeks postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/11/2025 |
| 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="6"
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 randomized controlled clinical trial aims to compare the visual performance and quality of vision after implantation of two different trifocal intraocular lenses in patients undergoing phacoemulsification for age-related cataract. Fifty patients aged 18 years or above with senile cataract will be recruited from the Department of Ophthalmology, Command Hospital (Eastern Command), Kolkata. Eligible patients without ocular comorbidities such as glaucoma, macular degeneration, or significant corneal astigmatism (>1.0 D) will be randomized into two equal groups of 25 each. Group A will receive BVI PhysIOL trifocal intraocular lenses, and Group B will receive Tecnis Synergy trifocal intraocular lenses.
Preoperative evaluation will include visual acuity assessment, slit-lamp examination, intraocular pressure measurement, and fundus examination. Standard phacoemulsification with IOL implantation will be performed in all cases. Postoperative follow-up will be done at one week and one month.
The primary outcomes will include uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm). Secondary outcomes will include assessment of glare and halos using the NEI near vision subscale and evaluation of visual quality using the Rasch-scored Quality of Vision (Q of V) questionnaire.
The total study duration will be 18 months for data collection and 2 months for data analysis. Ethical clearance has been obtained from the Institutional Ethical Committee, and written informed consent will be taken from all participants. The study will adhere to the principles of the Declaration of Helsinki and good clinical practice guidelines.
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