| CTRI Number |
CTRI/2025/04/084360 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hot air oven |
|
Scientific Title of Study
|
Effect of temperature on Intraocular lens unfolding time in cataract surgery |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSri Ganesh |
| Designation |
Chief Medical Director |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru.
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560070
India |
| Phone |
9845129740 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSushmithaSamak Sriganesh |
| Designation |
Chief Research Officer |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru.
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560070
India |
| Phone |
9448071800 |
| Fax |
|
| Email |
sush.samak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSanjay Kumar S |
| Designation |
Phaco refractive surgery fellow |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru.
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560070
India |
| Phone |
9964631396 |
| Fax |
|
| Email |
mr.sanju01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070
|
|
|
Primary Sponsor
|
| Name |
Nethradhama superspeciality eye hospital |
| Address |
Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrSanjay Kumar S |
Nethradhama superspeciality eye hospital |
Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru.
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9964631396
mr.sanju01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama 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 |
nil |
nil |
| Intervention |
We are comparing IOL unfolding time in catarct surgery with preheated IOL in hot air oven and IOL unfolding time |
we are comparing IOL between 2 groups
Comparing IOL unfolding time in catarct surgery with IOL at room temperature |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts,Posterior subcapsular cataract (LOCS 3 grading)
IOL power between +10D to +30D
In the bag IOL implantation
Hydrophobic acrylic IOL – Johnson & Johnson IOL – Synergy, Puresee, Eyehance, Tecnis, Sensar
|
|
| ExclusionCriteria |
| Details |
Hypermature/morgagnian/intumescent and brunescent cataracts more than NS 4
2. Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts less than 1500cells/ mm2
3. Small pupil less than 6mm, Intraoperative floppy iris sydnrome
4. History of glaucoma or intraocular inflammation
5. Macular disease or retinopathy, neuro-ophthalmic diseases, active infections,previous ocular surgery of any kind, any other ocular pathology.
Zonular dehiscence or weakness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assessand compare unfolding time of various IOL when preheated with hot air oven versus those at room temperature. |
post op follow up 1 day,15 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare total surgical time and to assess the outcome between 2 groups |
post op follow up 1 day,15 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
21/04/2025 |
| 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="3"
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
|
METHODOLOGY: This prospective, interventional, single center study will be approved by theinstitutional ethics committee of Nethradhama Super Speciality Eye Hospital andwill adhere to the tenets of declaration of Helsinki. Verbal and written informedconsent will be obtained from all patients participating in the study Primary Objective: To assess and compare unfolding time of various IOL when preheated with hot air oven versus those at room temperature.
|