| CTRI Number |
CTRI/2018/11/016475 [Registered on: 30/11/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To study changes in intraocular pressure before and after cataract surgery using non contact tonometer |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL STUDY OF CHANGES IN INTRAOCULAR PRESSURE BEFORE AND AFTER CATARACT SURGERY USING NON CONTACT TONOMETER IN SMALL INCISION CATARACT SURGERY AND PHACOEMULSIFICATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALEKYA K |
| Designation |
1st Year Postgraduate,Ophthalmology |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences,Eluru, Andhra Pradesh. |
| Address |
Department of ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, West Godavari District, Eluru, Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
87900116107 |
| Fax |
|
| Email |
alekyakesireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIVEKANAND U |
| Designation |
Professor |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences,Eluru, Andhra Pradesh. |
| Address |
Department of ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, West Godavari District, Eluru, Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8333044920 |
| Fax |
|
| Email |
vivekanandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIVEKANAND U |
| Designation |
Professor |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences,Eluru, Andhra Pradesh. |
| Address |
Department of ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, West Godavari District, Eluru, Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8333044920 |
| Fax |
|
| Email |
vivekanandu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study is conducted in Department of Ophthalmology, Alluri Sitarama Raju Academy of medical sciences, Medical college and hospital, Malkapuram, Eluru, Andhra Pradesh, 534005.
No external source of funding.
All the required equipment are available with in Department. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Vivekanand U |
Room 115, Department of Ophthalmology |
Department of ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, West Godavari District, Eluru, Andhra Pradesh.534005
West Godavari
ANDHRA PRADESH |
8333044920
vivekanandu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alluri Sitarama Raju 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
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Eye with age related cataracts undergoing surgery in our department( phacoemulsification or small incision cataract surgery) |
|
| ExclusionCriteria |
| Details |
Eye with any ocular pathology, traumatic cataract, eyes with glaucoma, Eye already on treatments for preexisting ocular pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in intraocular pressure measured by non contact tonometer |
At first week and fourth week post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
03/12/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we compare changes in intraocular pressure in patients who have undergone cataract surgery by small incision cataract surgery or phacoemulsification method for age related cataracts at 1st and 4th week consecutively using non contact tonometer in our department of ophthalmology. |