| CTRI Number |
CTRI/2025/09/094198 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Better corneal endothelium cell protection during cataract surgery in Type 2 Diabetes Mellitus patients using different Ophthalmic viscosurgical devices |
|
Scientific Title of Study
|
Evaluation of outcome of two different Ophthalmic viscosurgical devices 3 percent Sodium Hyaluronate and 4 percent Chondroitin sulphate vs 2 percent Hydroxy propyl methyl cellulose on endothelial cell count in Phacoemulsifiction cataract surgery in Diabetics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NALIN SAH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
Sankara Eye Hospital,General Ophthalmology department, Guntur - Vijayawada Highway, Pedakakani, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
07905033713 |
| Fax |
|
| Email |
greatnalin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANEES FATIMA |
| Designation |
OPHTHALMOLOGY CONSULTANT |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
Sankara Eye Hospital, General Ophthalmology Department, Guntur - Vijayawada Highway, Pedakakani, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
|
| Fax |
|
| Email |
aneesfatima@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
NALIN SAH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
Sankara Eye Hospital , General Ophthalmology Department Guntur - Vijayawada Highway, Pedakakani, Andhra Pradesh 522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
07905033713 |
| Fax |
|
| Email |
greatnalin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospoital Guntur - Vijayawada Highway, Pedakakani, Andhra Pradesh , India 522509 |
|
|
Primary Sponsor
|
| Name |
Sankara eye hospital Guntur |
| Address |
Guntur - Vijayawada Highway, Pedakakani, Andhra Pradesh 522509 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Nalin Sah |
SANKARA EYE HOSPITAL |
Guntur - Vijayawada Highway, General Ophthalmology Department , Pedakakani, Andhra Pradesh 522509
Guntur
ANDHRA PRADESH |
7905033713
greatnalin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SEH-Guntur |
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 |
| Comparator Agent |
3% Sodium Hyaluronate and 4% Chondroitin Sulphate,2% Hydroxy Propyl Methyl Cellulose |
Evaluate the outcomes of two comparator devices on Endothelial cell count in Phacoemulsification cataract surgery of patients with Diabetes Mellitus above 50 years of age |
| Intervention |
3% Sodium Hyaluronate and 4% Chondroitin Sulphate,2% Hydroxy Propyl Methyl Cellulose |
Evaluate the outcomes of two interventional devices on Endothelial cell count in Phacoemulsification cataract surgery of patients with Diabetes Mellitus above 50 years of age |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Grade of cataract- Nuclear sclerosis 1,2,3 and posterior subcapsular cataract 1,2,3,4 cortical cataract 1,2,3,4 by Lens Opacities Classification System(LOCS 3)
Pre operative Specular count>2000 cells/mm2
Uneventfull cataract surgery
Diagnosed with Type2 DM
|
|
| ExclusionCriteria |
| Details |
Grade of cataract-Nuclear Sclerosis 4,5,6 posterior subcapsular cataract 5 cortical cataract 5 (Lens Opacities Classification System Grading 3)
Corneal pathologies like fuchs endothelial dystrophy
Ocular pathology like Uveitis, pseudoexfoliation, glaucoma
Trauma
Previous eye surgery
Small rigid pupil(less than 5 mm)
Subluxated cataract
Complicated cataract
Study subjects lost to follow-up
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical Devieces |
Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical Devieces at baseline, 1 week,1 month,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Central corneal thickness increase to be evaluated in both groups of Ophthalmic viscosurgical devices |
Central corneal thickness increase to be evaluated in both groups of Ophthalmic viscosurgical devices at baseline , 1 week,1 month,1 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
23/09/2025 |
| 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="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
|
The study is a prospective interventional randomized control trial evaluating the effects of 3 percent Sodium Hyaluronate and 4 percent Chondroitin Sulphate vs 2 percent Hydroxy Propyl Methyl Cellulose on Endothelial cell count in 80 diabetic patients above 50 years of age undergoing Phacoemulsification cataract surgery in one center in Guntur India. The primary outcomes measure will all show decrease in endothelial cell count in 1 week,1 month and 3 months. The secondary outcome will show increase in Central corneal thickness in 1 week,1 month and 3 months. |