| CTRI Number |
CTRI/2024/04/065438 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Visual Outcomes and Satisfaction comaprison in patients undergoing Intraocular lens implantation via Phacoemulsification. |
|
Scientific Title of Study
|
Visual Outcomes and Satisfaction in patients undergoing Monofocal Intraocular lens (IOL) Vs Multi-Focal IOL Vs Extended Depth of Focus (EDOF) IOL Implantation via Phacoemulsification. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manan Mistry |
| Designation |
PG Resident Doctor Ophthalmology |
| Affiliation |
Aravind Eye Hospitals |
| Address |
IOL Department, Aravind Eye Hospitals, Poonamallee High Road, Numbal. Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
7045255628 |
| Fax |
|
| Email |
mistry.manan@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Haripriya Aravind |
| Designation |
Head of Department, Cataract & IOL Services |
| Affiliation |
Aravind Eye Hospitals |
| Address |
IOL Department, Aravind Eye Hospitals, Poonamallee High Road, Numbal. Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9442643561 |
| Fax |
|
| Email |
haripriya@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Manan Mistry |
| Designation |
PG Resident Doctor Ophthalmology |
| Affiliation |
Aravind Eye Hospitals |
| Address |
Room 210, PG Hostel, Aravind Eye Hospitals, Poonamallee High Road, Numbal. Chennai - 600077
TAMIL NADU
600077
India |
| Phone |
7045255628 |
| Fax |
|
| Email |
mistry.manan@outlook.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital Chennai |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Chennai |
| Address |
Aravind Eye Hospital, Poonamallee High Road, Numbal. Chennai - 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prabu Baskaran |
ARAVIND EYE HOSPITAL CHENNAI |
Aravind Eye Hospital, Poonamallee High Road, Numbal, Chennai - 600077
Chennai
TAMIL NADU |
9940152529
prabubaskaran@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insititutional Ethics Committee - Aravind Eye Hospital |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
A) Patients aged 40 and above.
B) Patients advised surgery, consenting and willing to undergo cataract surgery by phacoemulsification / MICS.
C) Uneventful phacoemulsification / MICS surgery |
|
| ExclusionCriteria |
| Details |
A) Patients with chronic co-morbidities like Diabetes Mellitus, Hypertension.
B) Any pre-existing corneal pathology/opacity leading to altered vision.
C) Any pre-existing retinal or macular pathology leading to sub-optimal post-op vision.
D) Inherited ocular conditions leading to Guarded visual prognosis.
E) Previously IOL implanted patient undergoing lens exchange procedure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Acuity differences across Near, Intermediate and Far vision will be measured and compared across Monofocals, Multifocals, EDOF IOLs. Multifocals should give spectacle free good visual acuity across all ranges. EDOF good visual acuity across Far and Intermediate vision. |
Post Operative Day 1, Post Operative Day 21 (3rd week), Post operative Day 90 (3rd month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction via IND-VFQ questionnaire on post operative visit.
-Spectacle independence
-Any adverse events related to the IOLs (glare, haloes, astigmatism, aberrations via iTrace. |
POD 1, 21 and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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)
|
15/04/2024 |
| 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 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 will employ a prospective, controlled, comparative trial design with the study duration being 1.5 years in Aravind Eye Hospital, Chennai.
Individuals who meet the specified inclusion and exclusion criteria will be invited to participate in the study after counselling and obtaining consent.
Patients will be in either the EDOF IOL or Multifocal IOL group or Monofocal group.
Pre-operatively
VA, Refraction, Slit lamp, Fundus exam, A scan biometry
VA, Refraction, Slit lamp, Fundus exam, A scan biometry, iTrace
VA, Refraction, Slit lamp, Fundus exam, A scan biometry
POD 1ST DAY
VA, Slit lamp, Fundus exam
POD 3RD WEEK
VA, Refraction, Slit lamp, Fundus exam
POD 3RD MONTH
VA, Refraction, IND - VFQ, Slit lamp, Fundus exam, iTrace
Patient satisfactions surveys (Indian – Visual Functioning Questionnaire) (3), visual acuity assessments (Vision, Refraction, A-scan biometry by Barrett II Universal formula, IOP, Slit lamp and fundus examination will be recorded at baseline (pre-operatively) and post operatively.
Follow up examinations will be conducted on Post – operative Day 1, 3rd week and 3rd month, measuring the same parameters mentioned above. Visual outcomes will be measured in terms of UCVA and BCVA for Near Vision, Intermediate Vision and Far Vision in logMAR form.
The tests being performed are already a part of the Standard Operating Protocol (SOP) of the hospital for patients undergoing cataract surgery. Additions are post- operative iTrace and Indian NEI - VFQ standardized validated questionnaire which will be furnished to the patient in his/her language of understanding and comprehension.
|