| CTRI Number |
CTRI/2026/03/105785 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing changes in eye power after cataract surgery with and without the use of cautery during the operation |
|
Scientific Title of Study
|
A comparative study of surgically induced astigmatism
in patients undergoing manual small incision cataract
surgery with and without sclera cautery A
prospective randomized controlled study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANGEL GRACE MARIE A |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Pondicherry Institute of Medical Sciences, Village no.20,Kalatthumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7825002275 |
| Fax |
|
| Email |
a.angelgracemarie8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amod Hansdak |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Pondicherry Institute of Medical Sciences, Village no.20,Kalatthumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9797572275 |
| Fax |
|
| Email |
a.annieflorencemary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANGEL GRACE MARIE A |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Ophthalmology, Pondicherry Institute of Medical Sciences, Village no.20,Kalatthumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7825002275 |
| Fax |
|
| Email |
a.angelgracemarie8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Ophthalmology, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, Kalathumettupathai, GANAPATHICHETTIKULAM , KALAPET, village 20, Puducherry- 605014, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| ANGEL GRACE MARIE A |
Pondicherry Institute of Medical Sciences |
Pondicherry Institute of Medical Sciences,
Department of Ophthalmology, Village no.20,Kalatthumettupathai, Ganapathichettikulam, Kalapet, Puducherry-605014
Pondicherry
PONDICHERRY |
07825002275
a.angelgracemarie8@gmail.com |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAUTERY |
COMPARISON OF SURGICAL INDUCED ASTIGMATISM USING KERATOMETRY WITHOUT SCLERAL CAUTERY IN GROUP 1 (NO.62) AND WITH USING CAUTERY IN GROUP 2 (NO.2) |
| Comparator Agent |
Without cautery |
COMPARISON OF SURGICAL INDUCED ASTIGMATISM USING KERATOMETRY WITHOUT SCLERAL CAUTERY IN GROUP 1 (NO.62) AND WITH USING CAUTERY IN GROUP 2 (NO.2) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Nuclear sclerosis grading 1-3 undergoing MSICS
2. Age more than 18 years
3. Patients having comorbidities like diabetes, hypertension, bronchial asthma are included |
|
| ExclusionCriteria |
| Details |
1. Patients with preexisting corneal pathology, complicated cataract, glaucoma and uveitis
2. Patients with any previous ocular surgery or trauma in the same eye
3. Patients who require suturing during surgery
Patients with advanced cataract
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objectives: To determine amount of Surgically-induced astigmatism with and without scleral cautery in patients undergoing manual small incision cataract surgery. |
At baseline, 1st postoperative day, 7TH postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objectives To study the effect of other factors like age, gender & comorbidities on postoperative outcomes
|
At Baseline, 1st postoperative day, 7TH postoperative day
|
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2026 |
| 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 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
|
This study is a prospective randomised control trial comparing the surgically induced astigmatism in 2 groups of patients who are undergoing manual small incision cataract surgery with and without cataract surgery. group -1 (no.62) patients undergoing manual small incision cataract surgery without scleral cautery and group -2 patients undergoing manual small incision cataract surgery with scleral cautery. Surgically induced astigmatism will be measured through keratometry preoperatively, on POD-1 and POD -7. The findings of this study may provide evidence regarding the necessity of scleral cautery in MSICS and its impact on postoperative visual outcomes, thereby helping optimize surgical technique and improving patient rehabilitation |