| CTRI Number |
CTRI/2022/01/039234 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
22/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To compare pupillary miosis because of photodisruption following femtosecond laser cataract surgery on two different machines.
|
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Scientific Title of Study
|
Comparison of pupillary miosis induced by photodisruption following femtosecond laser cataract surgery on two different operating systems
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman Managing Director |
| Affiliation |
Nethradhama superspeciality eye |
| Address |
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Brar |
| Designation |
Senior consultant and research director |
| Affiliation |
Nethradhama superspeciality eye |
| Address |
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
brar_sheetal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa R |
| Designation |
Fellow Phacorefractive |
| Affiliation |
Nethradhama superspeciality eye |
| Address |
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
dr.deeparswamy1@gmail.com |
|
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Source of Monetary or Material Support
|
| LENSAR,
2800 Discovery Dr, Orlando, FL 32826, USA |
|
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Primary Sponsor
|
| Name |
LENSAR |
| Address |
2800 Discovery Dr, Orlando, FL 32826, USA |
| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepa R |
Nethradhama superspeciality eye hospital |
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Bangalore
KARNATAKA |
8800846724
dr.deeparswamy1@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Netradhama superspeciality eye hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Catalys |
Study duration is 4 months.Pupillary miosis measurement of 50 patients by colvard pupillometer before and after femtosecond photodisruption on catalys machine |
| Intervention |
Lensar |
Study duration is 4 months. Pupillary miosis measurement of 50 patients by colvard pupillometer before and after femtosecond photodisruption on lensar machine |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 40-80 years
Patients having adequate pupil dilation (more than 7mm)
Patients with clear ocular media other than cataract in each eye
|
|
| ExclusionCriteria |
| Details |
Patients having non dilating pupil or dilation less than 6mm
Patients with pupillary , capsular or zonular adnormalities
Patients with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism
Patients with history of significant ocular trauma or prior ocular surgery
Patients with history of current inflammatory eye disease or other ocular diseases
Patients with history of rheumatic diseases or other immune diseases
Patients on systemic medications like NSAIDS or Steroids
Patients currently on glaucoma medications or any other topical medications
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the pupillary miosis induced by photodisruption following femtosecond laser cataract surgery on two different operating system namely LENSAR and CATALYS. |
Study involves measuring pupillary miosis on the day of surgery, it does not involve any post operative evaluation. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate consequences of decrease in pupil size and additional tools required for the management of the same |
•Study involves measuring pupillary miosis and consequences of decrease in pupil size and additional tools required for the managment on the day of surgery, it does not involve any post operative evaluation. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/01/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Femtosecond laser assisted cataract surgery was introduced to achieve high level of precision, accuracy and customization. In order to achieve good surgical outcome, intraoperative mydriasis is of paramount importance but the major drawback of FLACS is pupillary miosis leading to complications like posterior capsule rupture, vitreous loss, corneal edema and cystoid macular edema which in turn affects the final outcome of surgery and recovery. The main factor being significant increase of prostaglandins concentrations (PGE2) which induced the miosis. Other Inflammatory cytokines like IL-1β, IL-6 along with PGE2 are also significantly increased which leads to intraoperative miosis. In order to assess whether photodisruption following femtolaser will induce any pupillary miosis or not and to compare the extent of the same, using LENSAR and CATALYS FS laser systems, the present study will be conducted. To measure the pupillary size, colvard pupillometer will be used. |