| CTRI Number |
CTRI/2023/12/060942 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of cataract surgery on cornea. |
|
Scientific Title of Study
|
A comparison of endothelial cell injury in small incision cataract surgery versus phacoemulsification-An observational study(Dissertation work) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr swati choudhary |
| Designation |
1st year resident |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
Ophthalmology department, room no.-4,Old skin OPD,sir T hospital, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
8000287971 |
| Fax |
|
| Email |
swati93choudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr nilesh parekh |
| Designation |
Head of department of ophthalmology |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
Department of ophthalmology, Sir T general hospital and government medical college,bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428408788 |
| Fax |
|
| Email |
drnvparekh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Choudhary |
| Designation |
1st year resident |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
Department of ophthalmology, Sir T general hospital and government medical college,bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8000287971 |
| Fax |
|
| Email |
swati93choudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government medical college, Bhavnagar |
| Address |
Bus stand, near state road transport corporation, panwadi,
Bhavnagar, gujarat-364001. |
| 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 swati choudhary |
Sir T hospital, Bhavnagar |
Ophthalmology department,Sir T hospital, Bhavnagar, Gujarat-364001
Bhavnagar
GUJARAT |
8000287971
swati93choudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: H250||Age-related incipient cataract, (2) ICD-10 Condition: H250||Age-related incipient cataract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients >18 years of age undergoing cataract surgery. |
|
| ExclusionCriteria |
| Details |
Cataract patients having-:
Glaucoma
Any corneal pathology
History of chronic ocular inflammation
Traumatic cataract
Ocular surgeries or ocular trauma in the past.
Patients with any systemic disease like diabetes.
Inadvertent surgery. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess corneal endothelial cells injury by small incision cataract surgery versus phacoemulsification in terms of
Cell density
Cell shape
Cell size, by specular microscope. |
To assess corneal endothelial cells injury by small incision cataract surgery versus phacoemulsification in terms of
Cell density
Cell shape
Cell size, by specular microscope pre-opertaively and 2 weeks post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate post-operative complications |
15 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/01/2024 |
| 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="3"
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)?
Response - NO
|
|
Brief Summary
|
•After approval from ethics committee, study will be started. •All the admitted patients for cataract surgery who are fulfilling inclusion criteria And willing to give written informed consent will be taken for the study. •Pre-operative corneal endothelial cell density, shape and size will be measured by specular microscope (TOPCON SP-1P). •Patient will be taken for cataract surgery, SICS or Phacoemulsification. •Post-operative corneal endothelial cell density, shape and size will be measured by specular microscope.(TOPCON SP-1P) •All the data will be collected and analysed. |