| CTRI Number |
CTRI/2024/04/066108 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the effect of pupil dilating drops v/s injectable drugs in cataract surgery |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of intracameral fixed drug combination of mydriaticand anaesthetic in comparison with topical mydriatic for phacoemulsification in immature cataracts |
| 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 SOUBHAGYA S B PATIL |
| Designation |
Post graduate student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of ophthalmology,
Bangalore medical college and research Institute, New Tharugupet, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
7338233810 |
| Fax |
|
| Email |
soubhagyaspatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Bharati N |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Ophthalmology, Bangalore Medical College and Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9740809724 |
| Fax |
|
| Email |
bharath_64@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Dr Bharati N |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Ophthalmology, Bangalore Medical College and Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9740809724 |
| Fax |
|
| Email |
bharath_64@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research Institute, K.R.Road, fort,new tharugupet, Bangalore, 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research Institute |
| Address |
K. R. Road, fort, Bangalore, 560002 |
| Type of Sponsor |
Government 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 Soubhagya S B Patil |
MINTO ophthalmic hospital, BMCRI |
MINTO ophthalmic hospital, Regional Institute of Opthalmology BMCRI, opposite V.V.Puram police station, new tharugupet, Bangalore - 560002
Bangalore
KARNATAKA |
7338233810
soubhagyaspatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRACAMERAL FIXED DRUG COMBINATION OF MYDRIATIC AND ANAESTHETIC IN PHACOEMULSIFICATION IN IMMATURE CATARACTS |
Preopertively -
1. 15 minutes before the surgery, the patient will be administered with one drop of topical Proparacaine hydrochloride 0.5%. This will be administered thrice at an interval of 5 minutes.
Intraoperatively -
1. Patient will be administered 0.1 ml of a fixed drug combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1% intracamerally, only once, before initiating the Capsulorrhexis and left in the anterior chamber for a maximum of 10 seconds which is followed by washing it with Balanced Salt Solution.
2. Pupil dilation will be measured with Castroveijo Callipers before initiating a Capsulorrhexis. Phacoemulsification will then be continued.
3. Pupil dilation is measured again at the end of surgery, i.e. just before removing the eye speculum. The surgical time is expected to be around 15 minutes.
4. The results will be compared with those of the Comparator agent. |
| Comparator Agent |
TOPICAL MYDRIATIC FOR PHACOEMULSIFICATION IN IMMATURE CATARACTS |
Preopertively -
1. 30 minutes before the surgery, the patient will be administered with a combination eye drops containing mydriatic agents - Tropicamide 0.8% and Phenylephrine 5% in the eye to be operated. This will be administered thrice at an interval of 10 minutes.
2. 15 minutes before the surgery, the patient will also be administered with one drop of topical Proparacaine hydrochloride 0.5%. This will be administered thrice at an interval of 5 minutes.
Intraoperatively -
1. Pupil dilation will be measured with Castroveijo Callipers before initiating a Capsulorrhexis. Phacoemulsification will then be continued.
2. Pupil dilation is measured again at the end of surgery, i.e. just before removing the eye speculum. The surgical time is expected to be around 15 minutes.
3. The results will be compared with those of the interventional agent. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with senile immature cataract.
2. Patients willing to give informed consent for the study.
3. Patients who are to be taken up for phacoemulsification cataract surgery.
4. Patients with adequate preoperative pupillary dilatation. |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give consent for the study.
2. Cataracts other than senile immature cataracts.
3. concurrent ocular pathologies.
4. Patients using drugs that affect the pupillary diameter.
5. Gross corneal opacities that affect the visibility of pupil on slit lamp.
6. Patients known to be sensitive to all the study drugs.
7. Patients with involuntary eye movements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mydriasis |
before and after the administration of mydriatics in each group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain felt intraoperatively |
Immediate post operatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/05/2024 |
| 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="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
|
1. To evaluate the efficacy of intracameral fixed drug combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% in comparison with topical tropicamide 0.8% and phenylephrine 5% in terms of pupil dilatation. 2. To evaluate the efficacy of intracameral fixed drug combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% in comparison with topical tropicamide 0.8% and phenylephrine 5% in terms of patient comfort. 3. To evaluate the safety of intracameral fixed drug combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% |