CTRI

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CTRI Number

CTRI/2024/06/069482 [Registered on: 26/06/2024] Trial Registered Prospectively

Last Modified On:

25/06/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Other

Public Title of Study

A comparative study of effects of different techniques in small incision cataract surgery on vision, corneal curvature and corneal health

Scientific Title of Study

A comparative study of visual outcome, surgical induced astigmatism, endothelial cell loss after manual small incision cataract surgery by viscoexpression technique vs phacosandwich technique

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Palakala Sukrutha
Designation	Fellow Doctor
Affiliation	Sankara eye hospital, Guntur
Address	community outreach department, Sankara eye hospital, Guntur Vijayawada highway, Pedakakani Guntur ANDHRA PRADESH 522509 India
Phone	8179049338
Fax
Email	drsukrutha88@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Madhuri Venigalla
Designation	Consultant
Affiliation	sankara eye hospital, guntur
Address	Department of Cornea, Sankara eye hospital, Guntur Vijayawada highway, Pedakakani Guntur ANDHRA PRADESH 522509 India
Phone	9885483102
Fax
Email	madhurisivaram@gmail.com

Details of Contact Person
Public Query

Name	Palakala Sukrutha
Designation	Fellow Doctor
Affiliation	Sankara eye hospital, Guntur
Address	Community outreach department, Sankara eye hospital, Guntur Vijayawada Highway, Pedakakani Guntur ANDHRA PRADESH 522509 India
Phone	8179049338
Fax
Email	drsukrutha88@gmail.com

Source of Monetary or Material Support

Sankara eye hospital, Guntur, Andhra Pradesh, India pincode 522509

Primary Sponsor

Name	Sankara eye hospital
Address	Guntur Vijayawada highway, Pedakakani, Guntur, Andhra Pradesh, India 522509
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Palakala Sukrutha	Sankara eye hospital	Community outreach department, Guntur Vijayawada highway, Pedakakani 522509 Guntur ANDHRA PRADESH	8179049338 drsukrutha88@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Sankara eye hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical, (2) ICD-10 Condition: E119\|\|Type 2 diabetes mellitus without complications,

Intervention / Comparator Agent

Type	Name	Details
Intervention	technique of nucleus delivery in manual SICS	Using phacosandwich technique and viscoexpression during nucleus delivery
Comparator Agent	visual outcome, astigmatism and endothelial cell loss	we compare the visual outcome, astigmatism, endothelial cell loss using two different nucleus delivery techniques in manual SICS

Inclusion Criteria

Age From	45.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	1. Patients with best corrected visual acuity (LogMAR) less than or equals to 6/24 2. Patients with controlled diabetes, hypertension and normal IOP 3. Patients with no other ocular pathology 4. Patients with astigmatism less than 2D

ExclusionCriteria

Details

1. Patients with traumatic or complicated cataract
2. Patients with previous ocular surgery
3. Patients with small pupil (less than 6mm)
4. Patients with preoperative endothelial cell count less than 1500 cells/mm2
5. Patients with brown cataract

Method of Generating Random Sequence

Other

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. To assess vision 2. To assess astigmatism 3. To assess corneal endothelial cell count	1. Preoperative 2. Post operative day 1 3. Post operative day 30

Secondary Outcome

Outcome	TimePoints
To assess complications, if any	1. Post operative day 1 2. Post operative day 30

Target Sample Size

Total Sample Size="140"
Sample Size from India="140"
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)

07/07/2024

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 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 IS A COMPARATIVE STUDY OF VISUAL OUTCOME, SURGICAL INDUCED ASTIGMATISM AND CORNEAL ENDOTHELIAL CELL LOSS AFTER MANUAL SMALL INCISION CATARACT SURGERY BY VISCOEXPRESSION TECHNIQUE VERSUS PHACOSANDWICH TECHNIQUE, WHICH WILL BE CONDUCTED ON 140 VOLUNTARY PATIENTS FROM COMMUNITY OUTREACH DEPARTMENT AT SANKARA EYE HOSPITAL, GUNTUR. 140 PATIENTS WILL BE DIVIDED IN TO 2 GROUPS (A AND B) (70 PATIENTS IN EACH). DURING MANUAL SICS, PATIENTS FROM GROUP A, NUCLEUS WILL BE DELIVERED USING VISCOEXPRESSION TECHNIQUE, AND IN PATIENTS FROM GROUP B, NUCLEUS WILL BE DELIVERED USING PHACOSANDWICH TECHNIQUE. WE MEASURE VISUAL OUTCOME, CORNEAL ASTIGMATISM AND CORNEAL ENDOTHELIAL CELL COUNT PRE OPERATIVELY, POST OPERATIVELY ON DAY 1 AND DAY 30. INCIDENCE OF ANY COMPLICATIONS WILL BE NOTED. THE DURATION OF THE STUDY IS 6 MONTHS.