| CTRI Number |
CTRI/2024/04/065964 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of dry eye following topical phacoemulsification surgery |
|
Scientific Title of Study
|
Study on the Clinical Profile of Dry Eye following Topical Phacoemulsification |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Garg |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology,AVBRH Hospital,Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe) wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7528990123 |
| Fax |
|
| Email |
gargdiksha0912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin K Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology,AVBRH Hospital,Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe) wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887476011 |
| Fax |
|
| Email |
drpktidake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diksha Garg |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, AVBRH Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7528990123 |
| Fax |
|
| Email |
gargdiksha0912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital,Datta Meghe Institute of Higher Education and Research, Sawangi (meghe) wardha |
|
|
Primary Sponsor
|
| Name |
Acharya Vinoba Bhave Rural Hospital |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) wardha |
| Type of Sponsor |
Private 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 |
| Diksha Garg |
Acharya vinoba Bhave Rural Hospital |
Room No. 37, Department of Ophthalmology
Wardha
MAHARASHTRA |
7528990123
gargdiksha0912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe institute of Higher Education and Research, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who will present with senile cataracts during the study period but also have no history of dry eye syndrome
2.Patients giving their consent for the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with prior systemic diseases or syndromes associated with dry eye (example: diabetes mellitus, hypertension, deficiency of Vitamin A, diseases related to thyroid)
2.Patients who are on medications which have an additional side effect of causing ocular dryness
(eg: diuretics, psychotropic’s, antihistaminic, antidepressants, decongestants, beta blocker drugs, diuretics, and aspirin)(6)
3.Patients who wear contact lens
4.patients with various adnexal disorders, anterior or posterior segment disorders that affect the stability and secretion of tears,
patients on topical antiglaucoma medications that leads to ocular drying
5.conjunctivitis Which is chronic in nature
6.patients having small pupil or pupil which is difficult to dilate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| dryness evaluation by tear film break up time, visual acuity, dryness evaluation by Schirmers test, dryness evaluation by tear meniscus height, ocular surface disease index questionnaire for evaluating symptoms of dryness. |
day 1, day 7 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. dry eye
2. post operative inflammation
3. endophthalmitis |
day 30, day 60 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/04/2024 |
| 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="0"
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
|
The purpose of a study on the clinical profile of dry eye following topical phacoemulsification is likely to investigate the prevalence, severity, and characteristics of dry eye syndrome in patients who have undergone topical phacoemulsification surgery for cataracts. This research aims to understand the impact of the topical phacoemulsification surgery on tear film stability, ocular surface health, and symptoms of dry eye, as well as to identify potential risk factors or predictive markers for postoperative dry eye. Additionally, such a study may explore interventions or strategies to mitigate dry eye symptoms and improve patient outcomes following cataract surgery. |