| CTRI Number |
CTRI/2024/05/067597 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparison between topical phacoemulsification surgery and SICS in terms of patient satisfaction ratings and the anatomical and functional recovery of the eye |
|
Scientific Title of Study
|
Comparative study regarding the anatomical and functional recovery of eye and patient satisfaction score after small incision cataract surgery and topical phacoemulsification cataract surgery |
| 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 Zoya Javed |
| Designation |
Jr. Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Ophthalmology, Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8878824975 |
| Fax |
|
| Email |
zoyajaved258@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin K Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Ophthalmology, Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8878824975 |
| Fax |
|
| Email |
drpktidake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zoya Javed |
| Designation |
Jr. Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Ophthalmology, Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8878824975 |
| Fax |
|
| Email |
zoyajaved258@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Ophthalmology, Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India (442001) |
|
|
Primary Sponsor
|
| Name |
Acharya Vinoba Bhave Rural Hospital |
| Address |
Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 Zoya Javed |
Acharya Vinoba Bhave Rural Hospital |
Room no. 37, Department Of Ophthalmology, Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA |
8878824975
Zoyajaved258@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education and Research, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phacoemulsification cataract surgery |
In phacoemulsification, the cataractous lens is emulsified through a small incision of 2-3 mm, giving perfect visual outcomes. It involves the creation of a superior or temporal clear corneal incision of 2-3 mm, two side port incisions of at 2-3 clock hours on either side of the main wound. An ultrasonic probe is used to the trench, emulsify, and aspirate the cataractous lens from the main wound.
It is considered to provide lesser astigmatism, better and faster recovery of the eye when compared with the SICS. |
| Comparator Agent |
Small Incision Cataract surgery |
Small-incision cataract surgery (SICS) is a cost-effective, small-incision type of extracapsular cataract extraction (ECCE) that is commonly used in developing nations. In comparison with conventional ECCE, MSICS offers advantages of a self-sealing suture-free wound.
It involves creating a conjunctival flap and a sclero-corneal tunnel and then delivering the nucleus through it. The artificial IOL is also implanted through the same tunnel. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with uncomplicated, unilateral, or bilateral, immature senile cataracts of grade III or less
Patients from whom consent has been obtained. |
|
| ExclusionCriteria |
| Details |
1. Grade 4–5 cataracts
2.Mature, hyper-mature, complicated, genetic, and traumatic cataract
3.Patients with immature cataracts who also have other ocular comorbidities, have had eye trauma, or have undergone eye surgery.
4.Patients who suffer from any systemic diseases, like diabetes mellitus and raised blood pressure
5.Those who did not give consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Corneal Astigmatism
2. Visual Acquity
3. Tear film function test
4. Central Macular Thickness |
Day1, Day15, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Surgical Inflammation, Endophthalmitis, Pseudophakic Bullous Keratopathy and Other Complications after surgery Procedure. |
At day 30 & Day 60 |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
13/06/2024 |
| 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="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 study is being conducted to evaluate astigmatism through vertical and horizontal keratometry readings, Tear film function through Schirmer’s test 1 and central macular thickness through optical coherence tomography (OCT) pre- operatively & post- operatively in small incision cataract surgery & phacoemulsification under topical anaesthesia. Following consideration of the standards for inclusion and exclusion, the subjects for the case group study will go through an ophthalmological examination that includes detailed history pertaining to symptoms was recorded–onset, duration and, any aggravating factors, a routine general physical examination, a detailed ophthalmic examination including external eye examination, Visual acuity (both distance & near vision), Slit lamp examination to visualize the eye’s anterior segment and fundus examination. The patients are categorised under 2 groups- Patients undergoing SICS and Patients undergoing Phacoemulsification under topical anaesthesia. Post operatively, patients would be given an Antibiotic, an analgesic and a proton pump inhibitor tablet for 3 days. Eye drop 0.5% Moxifloxacin + 1% Prednisolone, eye drop Nepafenac 0.1% & eye drop 2% Homatropine would be given for 15 days. Patient follow up would be conducted on post operative day 1, day 15, day 30 & on day 60. |