| CTRI Number |
CTRI/2025/09/094459 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
How cataract surgery affects the cornea in people with fuchs uveitis |
|
Scientific Title of Study
|
Assesssment Of Corneal Endothelial Density In Fuchs Uveitis Patients Post-Cataract Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BINGI BINDU SWETHA |
| Designation |
MS Ophthalmology |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of ophthalmology ,Room no 26
Sankara Eye Hospital
Varthur Main Road, Vaikuntam Layout,Lakshminarayana Pura,KundaLahalli, Marathahalli,Munnekollal, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9989980420 |
| Fax |
|
| Email |
bingibinduswetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BINGI BINDU SWETHA |
| Designation |
MS Ophthalmology |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of ophthalmology ,Room no 26 Sankara Eye Hospital
Varthur Main Road, Vaikuntam Layout,Lakshminarayana Pura,KundaLahalli, Marathahalli,Munnekollal, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9989980420 |
| Fax |
|
| Email |
bingibinduswetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BINGI BINDU SWETHA |
| Designation |
MS Ophthalmology |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of ophthalmology
Room no26 Sankara Eye Hospital
Varthur Main Road, Vaikuntam Layout,Lakshminarayana Pura,KundaLahalli, Marathahalli,Munnekollal, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9989980420 |
| Fax |
|
| Email |
bingibinduswetha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Varthur Main Road, Vaikuntam Layout,Lakshminarayana Pura,KundaLahalli, Marathahalli,Munnekollal, Bengaluru, Karnataka 560037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bingi Bindu Swetha |
Sankara Eye Hospital |
Department of ophthalmology Room no 26 Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA |
9989980420
bingibinduswetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H201||Chronic iridocyclitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with Fuchs Uveitis with cataract
Patients who will undergo cataract surgery in this study period |
|
| ExclusionCriteria |
| Details |
Patients With Other Significant Ocular Conditions Affecting Corneal Endothelium
Incomplete Data
Loss to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Corneal Endothelial Cell Density |
1 week & 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Coefficient of Variation in Cell Size
Percentage of Hexagonal Cells |
1week &4weeks |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
19/09/2025 |
| 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
|
This study evaluates corneal endothelial cell parameters in patients with Fuchs Uveitis Syndrome (FUS) following cataract surgery. Using specular microscopy, endothelial cell density , cell morphology, and central corneal thickness are assessed and compared with age-matched controls. The objective is to determine the impact of FUS and cataract surgery on endothelial health, aiding in surgical planning and prognosis. |