| CTRI Number |
CTRI/2019/11/022169 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
01/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effect of phacoemulsification and manu small incision cataract surgery on endothelial cell changes |
|
Scientific Title of Study
|
Endothelial cell loss analysis in phacoemulsification versus small incision cataract surgery: A randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| u1111-1236-2518 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu Singh |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Ophthalmology
King Georges Medical University
Chowk
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8858916833 |
| Fax |
|
| Email |
ritusingh.diya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjiv Kumar Gupta |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Ophthalmology
King Georges Medical University
Chowk
Lucknow
King Georges Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
sanjiv204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjiv Kumar Gupta |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Ophthalmology
King Georges Medical University
Chowk
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
sanjiv204@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of the Research Cell
King Georges Medical University
Chowk
Lucknow |
|
|
Primary Sponsor
|
| Name |
King Georges Medical Univeristy |
| Address |
Chowk
Lucknow |
| Type of Sponsor |
Government 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 |
| Sanjiv Gupta |
King Georges Medical University |
Department of Ophthalmology
Lucknow
UTTAR PRADESH |
7905613731
sanjiv204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University Ethical 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 |
Manual Small Incision Cataract Surgery |
Surgical intervention after randomising the groups |
| Intervention |
Phacoemulsification |
Surgical intervention after randomising the groups |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Senile cataract of Nuclear grade III-IV (LOCS II classification) |
|
| ExclusionCriteria |
| Details |
1. Endothelial cell density less than 1500 cells/mm3
2. History of previous ocular surgery
3. History of any other coexisting oular disease
4. History of any intraoperative surgical complication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare endothelial cell changes in eyes undergoing phacoemulsification or manual small incision cataract surgery
|
After 6 weeks from cataract surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 . To compare the best corrected visual acuity (BCVA) in both the groups
2. To correlate the average phacoemulsification time (APT) used in phacoemulsification group with endothelial cell loss
3. To compare the results in different axial length groups
|
After 6 weeks from cataract surgery
|
|
|
Target Sample Size
|
Total Sample Size="266"
Sample Size from India="266"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
31/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Thesis prequel paper published on 1 October 2020
Gupta SK, Singh R, Sharma AK, Katiyar V, Kumar G. Is Manual Small Incision Cataract Surgery the Preferred Technique for Hard Cataract?. J Ophthalmology 2020,5(2):000201
Thesis paper sent for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM: To evaluate and compare endothelial cell changes in eyes undergoing phacoemulsification or manual small incision cataract surgery. OBJECTIVES: PRIMARY OBJECTIVE: To evaluate and compare endothelial cell changes in eyes undergoing phacoemulsification or manual small incision cataract surgery.
SECONDARY OBJECTIVE: 1. To compare the post-operative best corrected visual acuity (BCVA) in both the groups. 2. To correlate the average phacoemulsification time (APT) used in phacoemulsification group with endothelial cell loss 3. To compare the results in different axial length groups MATERIAL AND METHODS: Study setting: Study will be conducted in Department of Ophthalmology, King George’s Medical University, Lucknow and patients will be recruited from OPD. Informed consent will be taken in each case.
Study design: This study is to be conducted after ethical approval. It is a tertiary care hospital based, prospective, randomized, parallel group study to compare endothelial cell loss in phacoemulsification and manual small incision cataract surgery. Inclusion Criteria · Senile cataract of Nuclear grade III-V (LOCS III classification) Exclusion Criteria: • Endothelial cell density less than 1500 cells/mm3 • History of previous ocular surgery • Any other coexisting ocular disease • Intraoperative surgical complication Sample sixe: 152 patients were recruited Charan Biswas Formula ; n=z(1-α/2)2p(1-p)/d2 z(1-α/2)2 =1.96 at 95% CI p( prevalence) = 1.2 % d(margin of error) = 5% n (sample size)=266 Due to COVID-19 pandemic and Nationwide lockdown, the patient recruitment and follow-up was adversely affected. Therefore, the calculated sample size could not be met. A total of 152 patients were contrived for the study.
METHODOLOGY: Preoperative evaluation The patients will be randomized by computer generated random number allocation. Endothelial cell count, average size of cells, hexagonality, corneal cell thickness will be measured using specular microscope. Fixed frame analysis method will be used to capture the central area of cornea and four paracentral areas. Keratometry will be performed using IOL Master and axial length of eyes will be measured by A scan ultrasound probe. Postoperative evaluation The patients will be divided into 3 groups based on their axial lengths- small, moderate and large. Postoperatively, assessment will be performed at 6 weeks. At follow up visit- visual acuity, anterior segment slit lamp examination, fundoscopy, and specular microscopy will be performed to evaluate the corneal endothelium. Non parametric tests will be used to find significance among the axial lengths, pre- and post-operative endothelial cell count, average size, hexagonality, corneal thickness and visual acuity in the two study groups. A probability value of 0.05 will be accepted as the level of statistical significance. P <0.05 will be considered statistically significant. |