| CTRI Number |
CTRI/2024/05/067596 [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
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on Efficacy and Safety of Intraoperative Intracameral Injection Phenocaine in comparison with Preoperative Topical mydriatics in cataract surgery - Randomized control trial |
|
Scientific Title of Study
|
Efficacy and Safety of Intraoperative Intracameral Injection Phenocaine in comparison with Preoperative Topical mydriatics in cataract surgery- Randomized control 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 |
Dr Tharani M |
| Designation |
Post Graduate Trainee Ophthalmology |
| Affiliation |
Regional Institute of Medical Sciences Imphal |
| Address |
Duty Doctor Room 103
Male Eye ward 101
Department of Ophthalmology
Regional Institute of Medical Sciences
Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
8608944873 |
| Fax |
|
| Email |
tharanim2410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Y Chingsuingamba Meitei |
| Designation |
Professor And Head of Department of Ophthalmology |
| Affiliation |
Regional Institute of Medical Sciences Imphal |
| Address |
Head of department Room 102
Male Eye Ward 101
Department of Ophthalmology
Imphal West
MANIPUR
795004
India |
| Phone |
9436026405 |
| Fax |
|
| Email |
drcyumnam2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tharani M |
| Designation |
Post Graduate Trainee Ophthalmology |
| Affiliation |
Regional Institute of Medical Sciences Imphal |
| Address |
Duty Doctor Room 103
Male Eye Ward 101
Department of Ophthalmology
Regional Institute of Medical Sciences
Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
8608944873 |
| Fax |
|
| Email |
tharanim2410@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences Imphal |
|
|
Primary Sponsor
|
| Name |
Dr Tharani M |
| Address |
Duty Doctor Room 103
Male Eye Ward 101
Department of Ophthalmology
Regional Institute of Medical Sciences
Imphal |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tharani M |
RIMS Hospital , Imphal |
Eye operation theatre 5 and Male Eye Ward 101
Department of Ophthalmology
RIMS,IMPHAL
Imphal West
MANIPUR |
8608944873
tharanim2410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
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 |
Intracameral Mydriatics |
To Test the Efficacy And Safety of Intraoperative Intracameral Mydriatic Injection containing Lignocaine 1%
Phenylephrine 0.1%
Tropicamide 0.02% given once during the surgery intraoperatively and later can be given whenever needed
the Intervention will be done for 18 months |
| Comparator Agent |
Topical Mydriatics |
To Test the Efficacy And Safety Of Preoperative Topical Mydriatic Eye drop Tropicamide 0.8% and Phenylephrine 5% given in the eye to be operated every 15 minutes from before 1 hour of Surgery
Intervention is to be done for a period of 18 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Uncomplicated Cataract Patients
Pupil Diameter Atleast 6mm Preoperatively |
|
| ExclusionCriteria |
| Details |
Uveitis
Intake of alpha blockers
Use of topical or systemic NSAIDS/prostaglandins/miotics
Presence of corneal opacities,pupillary deformities
History of surgery in the same eye
Congenital cataract and history of ocular trauma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pupil size
2.Postoperative visual acuity
3.Corneal edema
4.ANTERIOR CHAMBER reaction
|
Post Operative Day 1
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/05/2024 |
| 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="20" |
|
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
|
Novelty of the study: Cataract surgery is a very common surgery undertaken in Ophthalmology. Adequate pupillary mydriasis and good anesthesia is crucial for successful cataract surgery. Thus, this study is undertaken to determine the efficacy and safety of intraoperative intracameral mydriatics in comparison with preoperative topical mydriatics.
Study design: Hospital-based Randomized control study Objectives of the study: To determine the efficacy and safety of intracameral mydriatic (tropicamide 0.02%+phenylephrine0.31%+lidocaine1%) in comparison with the standard preoperative mydriatics(tropicamide0.8%+phenylephrine5%). Participants: 42 patients in each group between the age of 40 – 90 years of age undergoing cataract surgery attending Ophthalmology OPD. Sampling/Recruitment /Collection: All uncomplicated cataract patients undergoing cataract surgery attending Ophthalmology OPD Regional Institute of Medical Sciences Hospital will be enrolled in the study. How randomization (if any) is planned: Block randomization(block size=4) Independent Variables (include intervention if trial): Age and sex Outcome Variables and measurements: pupil size, postoperative day one visual acuity,corneal edema and Anterior chamber(AC) inflammation scores. Plan of Statistical Analysis: Data collected in the proforma will be checked for consistency and completeness. Then they will be entered in the IBM SPSS version 21.0 software (IBM Corp. Armonk. NY, USA) for analysis. Descriptive statistics like mean, percentage and standard deviation will be used to represent age, sex. Pupil size will be analysed by Chi Square test .Postoperative day one visual acuity, corneal edema scores and AC inflammation scores will be compared and statistically analysed using the paired t-test and independent t-test. A p-value of <0.05 will be considered statistically significant.
|