| CTRI Number |
CTRI/2024/10/076097 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [prevention and treatment of dry eye related to refractive surgery] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to see the effectivness of intense pulsed light therapy in the treatment of dry eyes in patients who had undergone laser correction of refractive powers.
|
|
Scientific Title of Study
|
The efficacy of intense pulsed light therapy to treat post refractive surgery dry eye |
| 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 Annirudh Gupta |
| Designation |
DNB RESIDENT |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Room 5, ground floor, general OPD, Block 2, Nethradhama Superspeciality Eye Hospital,Kanakapura Main Road, 7th Block, Jayanagar, Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
9461430200 |
| Fax |
|
| Email |
dr.annirudhgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandanlatha Rao |
| Designation |
Consultant. |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
Room 5, ground floor, general OPD, Block 2, Nethradhama Superspeciality Eye Hospital,Kanakapura Main Road, 7th Block, Jayanagar, Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
8105784137 |
| Fax |
|
| Email |
dr.chandan684@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annirudh Gupta |
| Designation |
DNB RESIDENT |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
Room 5, ground floor, general OPD, Block 2, Nethradhama Superspeciality Eye Hospital,Kanakapura Main Road, 7th Block, Jayanagar, Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
9461430200 |
| Fax |
|
| Email |
dr.annirudhgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 5, ground floor, general OPD, Block 2, Nethradhama Superspeciality Eye Hospital,Kanakapura Main Road, 7th Block, Jayanagar, Bangalore 560070, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
NETHRADHAMA SUPERSPCIALITY EYE HOSPITAL |
| Address |
Room 5, ground floor, general OPD, Block 2, Nethradhama Superspeciality Eye Hospital,Kanakapura Main Road, 7th Block, Jayanagar, Bangalore 560070, Karnataka, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 ANNIRUDH GUPTA |
Room Number- OP05 NETHRADHAMA SUPERSPCIALITY EYE HOSPITAL |
Room 5, ground floor, general OPD, Block 2, Nethradhama Superspeciality Eye Hospital,Kanakapura Main Road, 7th Block, Jayanagar, Bangalore 560070, Karnataka, India
Bangalore
KARNATAKA |
9461430200
dr.annirudhgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee Nethradhama Super Speciality Eye Hospitall |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intense pulsed light therpy |
light is applied on skin below the eye from tragus to tragus 2 seconds at a point, 2 times which increases the mebomian gland function. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with refractive surgery.
Patients over 18 years of age.
Patient having clinical or sub clinical dry eye.
Patient willing to undergo a refractive surgery procedure.
Patients having adequate corneal thickness to undergo refractive surgery.
Patients with stable refraction for more than 1 year.
Patients giving consent to be part of study.
Patients who are willing to attend all the follow ups.
Skin type I-V according to Fitz Patrick.
|
|
| ExclusionCriteria |
| Details |
Patients without any refractive error and undergoing IPL.
Patients under 18 year of age.
Patients without dry eye.
Patient not willing to undergo refractive surgery.
Patient opting for other modality to treat dry eye.
Patient with unstable refraction in past 1 year.
Patients not giving consent to be part of study.
Patients who fail to attend all follow ups.
Patient who is uncooperative.
Patient with active ocular infection.
Patient with any open wound on eye or face.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tear film analysis by MS39, mebonian gland view and partial blink rate by lipiview, and refractive status of eye by HD analyser. |
Improvemnet in tear film status by MS39 Machine will be checked 1 month, 2 month and 3 months post last IPL session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Dry Eyes post refractive surgery |
2 more IPL sessions will be done post refractive surgery and Improvemnet will be checked 1 month, 2 month and 3 months post last IPL session |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
30/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
AIM
Through this study we aim to identify the Efficacy of Intense
Pulsed Light Therapy to Treat Post Refractive Surgery Dry Eyes.
OBJECTIVES
To study safety of IPL in post-operative dry eye.
Incidence of dry eye in post refractive surgery even after
IPL therapy.
Quality of vision in post refractive surgery dry eye patient
treated with IPL.
Difference between pre and post surgery IPL efficiency (d/t change
in corneal anatomy). To evaluate patient comfort during the procedure. PROCEDURE of
VISITS : Patients come with the
symptom of dry eye are sent for the tests for evaluation. After the tests results a
diagnosis of DRY EYE is made. Patient undergoes 1st
session of IPL. Patient undergoes 2nd
session of IPL after 15 days of 1ST session. Patient can undergo
REFRACTIVE SURGERY from 3rd day to 1 month after 2nd session
of IPL. Patient has to undergo 3rd
session of IPL after 1 month of the 2nd session of IPL. Patient has to undergo 4th
session of IPL after 1 month of the 3rd session of IPL. Patient visits for 1st
follow-up visit after 1 month of 4th session of IPL. Patient visits for 2nd
follow-up visit after 2 month of 1st follow-up visit. Patient visits for 3rd
follow-up visit after 3 month of 2nd follow-up visit. PROCEDURE OF
IPL: The machine used for IPL
therapy is LUMENIS M22.Eyes of the patient are
covered, cupping gel is applied on face from tragus to tragus. The hand-piece of IPL has
an optical filter either 560 or 590, based on the skin type of patient. A light guide is also
placed in the slot provided in the hand piece and the light is delivered in
coupling gelly from tragus to tragus in 2 passes. After the delivery of first
light the observation is made for skin changes so as to assess the damage
caused if any. If any damage is observed the optical filter is decreased. The subsequent light is
delivered adjacent to the previous one taking care that the two points don’t
overlap. Patient is advised to not
get exposed to sunlight for 48hrs if it is unavoidable use a liberal amount of
suns screen on the treated area.
|