| CTRI Number |
CTRI/2025/10/096085 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Different Eye Protection Gels Used During Cataract Surgery in Diabetic Patients |
|
Scientific Title of Study
|
Comparative Study Of Surgical Outcomes Using Different Viscoelastic Agents In Topical Phacoemulsification Among Diabetic Patients With Cataracts At A Tertiary Care Centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savsani Varnil Rajeshbhai |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department Of Ophthalmology, Ground Floor, AVBRH building, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7575858880 |
| Fax |
|
| Email |
varnil99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Daigavane |
| Designation |
Professor And Head Department Of Ophthalmology |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department Of Ophthalmology, Ground Floor, AVBRH building, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021736568 |
| Fax |
|
| Email |
hod.ophthalmologyjnmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Daigavane |
| Designation |
Professor and Head Department Of Ophthalmology |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department Of Ophthalmology, Ground Floor, AVBRH building, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021736568 |
| Fax |
|
| Email |
hod.ophthalmologyjnmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi(meghe), Wardha, India 442001 |
| 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 |
| Dr Savsani Varnil Rajeshbhai |
Acharya Vinoba Bhave Rural Hospital |
Room number 24,Department of Ophthalmology, ground floor, A block, Sawangi Meghe,Wardha,Maharashtra,India442001
Wardha
MAHARASHTRA |
7575858880
varnil99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hypromellose Ophthalmic Solution USP (Hyprosol) |
Hypromellose Ophthalmic Solution (Hyprosol) is a dispersive viscoelastic agent administered intraoperatively into the anterior chamber via a sterile cannula under topical anesthesia. It has lower molecular weight and viscosity compared to cohesive agents, allowing it to spread evenly within the anterior chamber. This property makes it particularly effective in coating and protecting delicate ocular tissues, such as the corneal endothelium, during surgery. By reducing surface tension and adhering to intraocular structures, it enhances surgical precision and minimizes the risk of tissue trauma during maneuvers like capsulorhexis, phacoemulsification, and intraocular lens implantation. |
| Intervention |
Sodium Hyaluronate Ophthalmic Solution (Hyloject) |
Sodium Hyaluronate Ophthalmic Solution (Hylojet) is a prefilled, cohesive viscoelastic agent administered intraoperatively into the anterior chamber under topical anesthesia. Formulated with high molecular weight polymers, it exhibits cohesive properties, forming a single mass that helps maintain anterior chamber depth, stabilize the surgical environment, and protect the corneal endothelium. It facilitates precise surgical maneuvers, including capsulorhexis, phacoemulsification, and intraocular lens (IOL) implantation, thereby enhancing surgical safety and efficiency. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with senile cataract and diagnosed diabetes mellitus.
2.Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1.Preoperative glaucoma or IOP more than 20 mmHg.
2.Intraoperative complications like manual dilatation of pupil, posterior capsular rent, sulcus IOL placement.
3.Presence of subluxation, pseudoexfoliation, or other associated ocular/corneal pathology.
4.Previous intraocular surgery in study eye. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative corneal endothelial cell loss associated with different viscoelastic agents |
Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Acuity (Both Uncorrected and Corrected Visual Acuity) |
Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month |
| Intraocular Pressure (IOP) Changes |
Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month |
| Postoperative Complications Related To Viscoelastic Agents |
Post-Operative Day 1, Day 15, and 1 Month |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="2"
Months="0"
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 prospective, comparative, open-label interventional study to evaluate surgical outcomes of different viscoelastic agents in topical phacoemulsification among diabetic patients with cataract at a tertiary care centre. A total of 174 patients (87 in each group) will be included. Group 1 will receive Sodium Hyaluronate Ophthalmic Solution (Hyloject) and Group 2 will receive Hypromellose Ophthalmic Solution USP (Hyprosol) during cataract surgery. The primary outcome is postoperative corneal endothelial cell loss. Secondary outcomes include visual recovery, intraocular pressure changes, and postoperative complications. The study duration will be 2 years. |