| CTRI Number |
CTRI/2025/07/091365 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Corneal changes After Cataract Surgery |
|
Scientific Title of Study
|
Corneal Thickness and Corneal Endothelial Cell Loss after Phacoemulsification in Different Grades of Nuclear Sclerosis |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Reddy |
| Designation |
DNB OPHTHOLOGY Resident |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room No 240
Adminstrative block ,
Sankara Eye Hospital ,
Guntur - Vijayawada HWY
Pedakakani ,Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8074973893 |
| Fax |
|
| Email |
maramaparna1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashidhar Banigallapati |
| Designation |
Senior ophthalmology Consultant |
| Affiliation |
|
| Address |
Room No 240
Adminstrative block ,
Sankara Eye Hospital ,
Guntur - Vijayawada HWY
Pedakakani ,Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
|
| Fax |
|
| Email |
shashidhar@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Reddy |
| Designation |
DNB OPHTHOLOGY Resident |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room No 240
Adminstrative block ,
Sankara Eye Hospital ,
Guntur - Vijayawada HWY
Pedakakani ,Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8074973893 |
| Fax |
|
| Email |
maramaparna1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital
Room No 240
Adminstrative block
Guntur Vijayawada HWY
Pedakakani Andhra Pradesh
522509 |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Reddy |
| Address |
Sankara Eye Hospital
Room No 240
Adminstrative block
Guntur Vijayawada HWY
Pedakakani Andhra Pradesh
522509 |
| 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 Aparna Reddy |
Sankara Eye Hospital |
Room No 240
Adminstrative block
Guntur Vijayawada HWY
Pedakakani Andhra Pradesh
522509
Guntur
ANDHRA PRADESH |
8074973893
maramaparna1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital Institutional 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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients ready to give written informed consent.
2 Patient WITH CATARACT, 50 to 70 years of age, both sexes with no prior ocular disease,
3 Clear cornea devoid of any corneal dystrophy and degenerations, undergoing routine phacoemulsification surgery,
4 Patients with corneal ECD of more than 2000 cellmm.
|
|
| ExclusionCriteria |
| Details |
1 Preoperative endothelial count less than 2000 cellsmm,
2 Any type of corneal pathology such as corneal degeneration and corneal dystrophy, contact lens wear history.
3 Any complicated cataract other than senile nuclear cataract are excluded.
4 Previous ocular surgeries,trauma ,chronic glaucoma
5 Patients with inadequate follow-up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Corneal thickness and Corneal endothelial cell loss after Phacoemulsification in different grades of Nuclear sclerosis |
Preoperative
Postoperative 1st week
Postoperative 1st month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/08/2025 |
| 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="0"
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
|
Cataract is a major and the biggest cause of treatable blindness worldwide . Phacoemulsification is considered nowadays the surgery of choice for cataract removal worldwide. Phacoemulsification surgery can cause corneal endothelial cell loss owing to the dissipated ultrasound energy during the procedure. Exaggeration of corneal endothelial cell loss can lead to postoperative complications such as delayed regression of corneal edema or even permanent edema of the cornea or bullous keratopathy Loss of endothelial function by the damage of endothelial cells can lead to increased corneal thickness and decreased corneal transparency because of increased stromal hydration due to compromised pump function . So my Aim is to study Corneal thickness and Corneal endothelial cell loss after Phacoemulsification in different grades of Nuclear sclerosis |