| CTRI Number |
CTRI/2024/07/069852 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study to see the effect of intracameral mydriatics versus topical mydriatics in pupil dilatation for phacoemulsification cataract surgery. |
|
Scientific Title of Study
|
COMPARATIVE STUDY TO SEE THE EFFECT OF INTRACAMERAL MYDRIATICS VERSUS TOPICAL MYDRIATICS IN PUPIL DILATATION FOR 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 Shivi Srivastava |
| Designation |
Junior resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
OPD No.- 10, Upgraded Department of Ophthalmology, LLRM Medical College, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7985988080 |
| Fax |
|
| Email |
drshivi.eyesurgeon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka Gupta |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Upgraded department of Ophthalmology, LLRM Medical College, Meerut
Nai sarak, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
09412201639 |
| Fax |
|
| Email |
dralkag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Gupta |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Upgraded department of ophthalmology, LLRM Medical college
Nai sarak, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9412201639 |
| Fax |
|
| Email |
dralkag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Upgraded Department of Ophthalmology, LLRM Medical College, Meerut, Uttar Pradesh, India. PIN Code - 250004 |
|
|
Primary Sponsor
|
| Name |
Shivi Srivastava |
| Address |
OPD No. 10, Upgraded department of Ophthalmology, LLRM Medical College, Meerut, Uttar Pradesh, India. PIN code - 250004 |
| 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 |
| Dr Shivi Srivastava |
Sardar Vallabh Bhai Patel Hospital, Meerut |
OPD 10, First floor, Upgraded department of ophthalmology, LLRM medical college, Meerut
Meerut
UTTAR PRADESH |
7985988080
drshivi.eyesurgeon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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 |
Intracameral injection of fixed dose combination (FDC) of mydriatics for pupil dilation |
drug and dose - A FDC mixture of 0.2 % tropicamide and 2% phenylephrine and 1% preservative free lidocaine
Frequency - injected into the anterior chamber through the side port at the beginning of surgery
Duration - to maintain stable mydriasis throughout the surgery |
| Comparator Agent |
Topical mydriatic eye drops for pupil dilation |
Drug and dose - Eye drop which is a mixture of 0.8% tropicamide and 5% Phenylephrine
Frequency - 4 times every 10 minutes
Duration - starting 40 mins before surgery into the eye to be operated. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Ability to give informed consent
Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens
No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.)
No history of previous intraocular surgery in the eye of interest.
|
|
| ExclusionCriteria |
| Details |
Previous or concurrent use of alpha-antagonist medication
Progressive corneal pathology affecting pupil magnification or measurement
Uncontrolled hypertension
Allergy to the drug used
Complicated cataract
Pseudoexfoliation and exfoliation syndromes
History of ocular trauma or inflammation in the previous 3 months |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pupil size in front of the slit lamp and by surgical callipers 3 times during the procedure |
Baseline on Pre-operative evaluation day,
On the operating table after betadine wash,
Before initiating capsulorhexis,
At the end of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Blood pressure
2. Pulse rate
|
Both will be measured thrice Peri-operatively by digital BP machine in supine position on the left upper arm of the patient at the level of the heart.
Baseline on Pre-operative evaluation day,
10mins before the surgery, Immediate post-operative period,
On post-operative Day 1 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [glittergirl.shivi@gmail.com].
- For how long will this data be available start date provided 19-06-2025 and end date provided 19-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Traditional methods of achieving optimal pupil dilatation during
phacoemulsification rely on topical mydriatics, such as
tropicamide 0.8% and phenylephrine 5%.
However, the emergence of intracameral mydriatics, specifically a fixed-dose
combination (FDC) comprising tropicamide 0.2%, phenylephrine 2%, and
preservative-free lidocaine 1%, presents a promising alternative. The existing
literature acknowledges the advantages of intracameral mydriatics, including
potentially faster onset, prolonged duration of action, and reduced dependence
on patient compliance. However, the majority of studies and safety data
primarily pertain to populations outside the Indian subcontinent. Given the
unique characteristics of the Indian demographic, such as varied genetic
predispositions and environmental factors, there is a compelling need to assess
the safety and efficacy of intracameral mydriatics specifically within this
population. This study aims to address this critical gap in knowledge by
conducting a comprehensive comparative analysis of the effects of intracameral
mydriatics versus topical mydriatics in achieving pupil dilatation for
phacoemulsification cataract surgery. By meticulously evaluating parameters
such as speed, extent, and sustainability of pupil dilation, as well as
monitoring potential adverse events, the study seeks to provide valuable
insights into the appropriateness of intracameral mydriatics within the Indian
context. Ultimately, the findings are expected to inform clinical practice,
optimize surgical outcomes, and contribute to the ongoing refinement of
cataract surgery protocols in the pursuit of enhanced patient care. |