| CTRI Number |
CTRI/2025/03/083370 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of change in corneal curvature after 2 types of incisions in cataract surgery |
|
Scientific Title of Study
|
A comparative study of surgically induced astigmatism (SIA) in temporal and on-axis clear corneal incision in patients undergoing phacoemulsification- Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhashitha Chowdary Koripalli |
| Designation |
Post graduate |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry institute of medical sciences, Ganapathichettikulam, Kalapet, Puducherry, India- 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9550233688 |
| Fax |
|
| Email |
kbhasitha1997@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Venipriya. S |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry institute of medical sciences, Ganapathichettikulam, Kalapet, Puducherry, India- 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9789700290 |
| Fax |
|
| Email |
venipriyadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhashitha Chowdary Koripalli |
| Designation |
Post graduate |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry institute of medical sciences, Ganapathichettikulam, Kalapet, Puducherry, India- 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9550233688 |
| Fax |
|
| Email |
kbhasitha1997@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Pondicherry institute of medical sciences, Ganapathichettikulam, Kalapet, Puducherry, India- 605014 |
|
|
Primary Sponsor
|
| Name |
Bhashitha Chowdary Koripalli |
| Address |
Pondicherry institute of medical sciences, Ganapathichettikulam, Kalapet, Puducherry, India- 605014 |
| 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 |
| Bhashitha Chowdary Koripalli |
Pondicherry institute of medical sciences |
Department of ophthalmology, second floor, room number- 354 Ganapathichettikulam, Kalapet, Puducherry, India- 605014
Pondicherry
PONDICHERRY |
9550233688
kbhasitha1997@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE 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, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Site of surgical incision
no drug used
|
On-axis clear corneal incision
90 days |
| Intervention |
Site of surgical incision
no drug used |
Temporal clear corneal incision
90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years, patients undergoing phacoemulsification with corneal astigmatism less than 3.00 D
|
|
| ExclusionCriteria |
| Details |
Corneal sutures, any h/o ocular surgery, corneal opacity, any other ocular diseases which might decrease the visual potential after cataract surgery
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| corneal curvature, astigmatism, vision pre and postop |
Baseline, day 1, 1 week, 3 weeks, 9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| corneal curvature and vision pre and postop |
preop and 3months followup |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/04/2025 |
| 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="2"
Months="0"
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
|
SURGICALLY INDUCED ASTIGMATISM (SIA) IN TEMPORAL AND ON-AXIS CLEAR CORNEAL INCISION IN PATIENTS UNDERGOING PHACOEMULSIFICATION – RANDOMIZED CONTROLLED TRIAL Primary objectives: To compare the
Surgically Induced Astigmatism (SIA) between Temporal Clear Corneal Incision (TCCI)
and On-Axis Clear Corneal Incision (OCCI) in patients undergoing
phacoemulsification
Secondary objectives:
1. To compare the coupling ratio
between temporal clear corneal (TCCI) and On-Axis Clear Corneal Incision (OCCI)
in patients undergoing phacoemulsification
2. To compare the Visual outcome
between temporal clear corneal (TCCI) and On-Axis Clear Corneal Incision (OCCI)
in patients undergoing phacoemulsification
Description of study groups (for comparative/analytical studies only): In this study, the participants will be divided into 2 groups GROUP A – patients undergoing phacoemulsification with Temporal Clear Corneal Incision GROUP B - On axis Clear corneal incision. Pre and post op keratometry values, astigmatism, coupling ratio, visual acuity will be compared between the two groups.
|