| CTRI Number |
CTRI/2020/10/028742 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
28/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the four different cracking techniques in brown coloured cataract during cataract surgery by machine |
|
Scientific Title of Study
|
Comparative study of four standard techniques of nucleus management in brunescent cataract during Phacoemulsification |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Madhumita |
| Designation |
Resident Post Diploma DNB Ophthalmology |
| Affiliation |
Sankara Eye Hospital Guntur |
| Address |
Department of Cornea
Sankara Eye Hospital
Guntur Vijayawada Expressway
Pedakakani
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8500408079 |
| Fax |
|
| Email |
drmmadhumita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Shashidhar |
| Designation |
Cornea Consultant |
| Affiliation |
Sankara Eye Hospital Guntur |
| Address |
Department of Cornea
Sankara Eye Hospital
Guntur Vijayawada Expressway
Pedakakani
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9440325143 |
| Fax |
|
| Email |
drshashib@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Madhumita |
| Designation |
Resident Post Diploma DNB Ophthalmology |
| Affiliation |
Sankara Eye Hospital Guntur |
| Address |
Department of Cornea
Sankara Eye Hospital
Guntur Vijayawada Expressway
Pedakakani
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8500408079 |
| Fax |
|
| Email |
drmmadhumita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital Guntur |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital Guntur |
| Address |
Sankara Eye Hospital
Guntur Vijayawada Expressway
Pedakakani
Guntur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Madhumita |
Sankara Eye Hospital |
Department of Cornea
Sankara Eye Hospital
Guntur Vijayawada Expressway
Pedakakani
Guntur 522509
Guntur
ANDHRA PRADESH |
8500408079
drmmadhumita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Not applicable |
Not Applicable |
| Intervention |
PHACOEMULSIFICATION |
Phacoemulsification by four nucleotomy techniques (Divide and Conquer, Stop and Chop, Horizontal Chop and Vertical chop) in brown cataract |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with brunescent cataract. (nuclear opalascence (NO) grade 6 according to LOCS III classification)
2.Patients belonging to age group >50 years
|
|
| ExclusionCriteria |
| Details |
1.Specular microscopy counts less than 2000 cells/mm2
2.Small pupil (less than 3mm)
3.Pseudoexfoliation
4.Shallow anterior chamber depth (less than one fourth the corneal thickness), as according to Van Herick’s grading of peripheral anterior chamber depth.
5.Corneal disorders like corneal opacity, degenerations and dystrophies.
6.Subluxated/traumatic cataract
7.Ocular inflammation
8.Coexisting retinal pathologies or undergone previous retinal surgeries
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To record in all the four nucleotomy techniques, the intraoperative parameters such as
a)Mean phaco time (min)
b)Mean phaco power (%)
c)Effective Phaco Time (EPT)
2. To compare the endothelial parameters like cell density, Coefficient of variation (CV) and central corneal thickness (CCT) before and after the surgery in each of these techniques.
|
On the day of presentation and follow up at 1 week and 1 month postoperatively |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To record visual acuity |
On the day of presentation and at 1 week and 1 month postoperatively |
|
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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)
|
31/10/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Performing Phacoemulsification in brown cataracts has many challenges with a high complication rate even in experienced hands. In brunescent cataract, the hard, unyielding leathery fibres of the lens nucleus
poses a great difficulty to perform phacoemulsification. Hence many variations in the nucleotomy techniques is also being practiced with an aim to achieve an uneventful and safe outcome. Thus use of safer phaco techniques that will significantly reduce the phaco time and energy and consequential corneal endothelial cell loss can be more rewarding for both the patient and surgeon because of profound restoration of vision and a successful outcome.
Hence this study is undertaken, to compare the four nucleotomy techniques (Divide and Conquer, Stop and Chop, Horizontal Chop and Vertical Chop) in terms of its intraoperative paratemeters like (phaco
time and phaco energy), the corneal endothelial parameters (cell density, coefficient of variation and central corneal thickness) and visual acuity.
|