| CTRI Number |
CTRI/2024/01/061893 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Cell count in patients with white ring around the cornea |
|
Scientific Title of Study
|
Assessment of change in Endothelial Density pre and post cataract surgery in patients with arcus senilis |
| Trial Acronym |
ASEC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manaswini Reddy |
| Designation |
Primary DNB Resident |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room no 25, Cornea clinic, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9849863341 |
| Fax |
|
| Email |
chinnumanureddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Josephine Christy |
| Designation |
Head of the Department Cornea and Refractive services |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room no 25, Cornea clinic, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9994549584 |
| Fax |
|
| Email |
josephine@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manaswini Reddy |
| Designation |
Primary DNB Resident |
| Affiliation |
Aravind eye hospital, Pondicherry |
| Address |
Room no 25, Cornea clinic, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9849863341 |
| Fax |
|
| Email |
chinnumanureddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry-605007, India |
|
|
Primary Sponsor
|
| Name |
Dr. Manaswini Reddy |
| Address |
Cornea clinic, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry |
| 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 Manaswini Reddy |
Aravind Eye Hospital, Pondicherry |
Room no 25, Cornea clinic
Pondicherry
PONDICHERRY |
9849863341
chinnumanureddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H184||Corneal degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
It is an observational study. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 All patients with arcus senilis diagnosed on clinical slit lamp examination
2 Patients undergoing cataract surgery(Phacoemulsification or Manual small incision cataract surgery) |
|
| ExclusionCriteria |
| Details |
1 Patients with other corneal diseases affecting endothelial counts or transparency
2. Sick and debilitated elderly patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in endothelial density pre and post cataract surgery in patients with arcus senilis |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the visual improvement after cataract surgery in this set of study population.
To observe the baseline endothelial reserve of these patients with arcus senilis in comparison with the normal population.
To compare the endothelial cell density after cataract surgery in patients who have undergone Phacoemulsification or Manual small incision cataract surgery |
Day 0, Day 1 and Month 1 |
|
|
Target Sample Size
|
Total Sample Size="329"
Sample Size from India="329"
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)
|
30/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Primary objectives:
To assess the changes in endothelial density pre and post cataract surgery in patients with arcus senilis using specular microscopy
Secondary objectives:
1. To study the baseline endothelial cell reserve, cell morphology and density in patients with arcus senilis
2. To analyze the visual outcome after cataract surgery in patients with arcus senilis
3. To assess the complications rate in cataract surgery among patients with arcus senilis
Expected outcome:
The baseline endothelial count and morphology in patients with arcus senlis to be different from the normal population.
|