| CTRI Number |
CTRI/2025/12/098429 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how removing a cataract by phacoemulsification from one eye affects the other, untreated eye |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY ON THE OBJECTIVE CHANGES IN THE FELLOW EYE AFTER UNILATERAL 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 |
PEDDIRAJU LAKSHMI VIHARIKA |
| Designation |
post graduate 1st year |
| Affiliation |
Alluri Sitarama Raju Academy Of Medical Sciences |
| Address |
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8317582163 |
| Fax |
|
| Email |
viharika998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pakalapati Pradeep |
| Designation |
Professor |
| Affiliation |
Alluri Sitarama Raju Academy Of Medical Sciences |
| Address |
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8096450301 |
| Fax |
|
| Email |
pradeepdr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PEDDIRAJU LAKSHMI VIHARIKA |
| Designation |
post graduate 1st year |
| Affiliation |
Alluri Sitarama Raju Academy Of Medical Sciences |
| Address |
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8317582163 |
| Fax |
|
| Email |
viharika998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peddiraju Lakshmi Viharika
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005 |
|
|
Primary Sponsor
|
| Name |
Peddiraju Lakshmi Viharika |
| Address |
Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru, 534005 |
| 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 |
| Peddiraju Lakshmi Viharika |
Alluri Sitaramaraju academy of medical sciences |
Room No. 115, Department of Ophthalmology.
West Godavari
ANDHRA PRADESH |
8317582163
viharika998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASRAMS BHR 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 |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
BCVA MORE THAN 6/12 IN THE OTHER EYE
NO SIGNIFICANT CATARACT SURGERY IN THE OTHER EYE
NO PLANNED CATRACT SURGERY WITHIN 6 MONTHS |
|
| ExclusionCriteria |
| Details |
history of ocular trauma, uveitis or intra ocular surgery in either eye.
Glaucoma, Psuedoexfoliation syndrome, angle anomalies
System diseases like Diabetes or Hypertension. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in ANTERIOR CHAMBER DEPTH or LENS THICKNESS suggestive of accommodative alterations
Insights into contralateral neuro-ophthalmic feedback mechanisms. |
Baseline pre-operatively, 24 hours post-operatively, 1 week post-operatively, 4 weeks post-operatively |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/12/2025 |
| 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="6"
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
|
To evaluate objective changes in the fellow (unoperated) eye following unilateral
phacoemulsification. Objectives: 1. To assess changes in intraocular pressure (IOP), visual acuity(VA) in the fellow eye
postoperatively. 2. To evaluate changes in anterior chamber depth (ACD), lens thickness (LT), and axial
length (AL) using optical biometry. 3. To analyze contrast sensitivity in the fellow eye by using digital contrast sensitivity chart 4. To determine stereopsis in the fellow eye by using Titmus fly test. 5. To assess any correlation between the severity of cataract or surgery duration in the
operated eye and changes in the fellow eye. |