| CTRI Number |
CTRI/2019/01/017149 [Registered on: 17/01/2019] Trial Registered Prospectively |
| Last Modified On: |
16/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [use of small and medium sized cones in relax smile patients for docking] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of outcomes in patients undergoing SMILE surgery for refractive errors using two different cones |
|
Scientific Title of Study
|
Comparison of clinical outcomes and visual quality using medium versus small cone in patients undergoing Relex Smile with large corneal diameters |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
MS DNB CMD Nethradhama Super-speciality eye hospital |
| Affiliation |
|
| Address |
#256/14 kanakpura main road 7th block Jayanagar
Bangalore
560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sri Ganesh |
| Designation |
MS DNB CMD Nethradhama super-speciality eye hospital |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
#256/14 kanakpura main road 7th block Jayanagar
bangalore
560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr sri ganesh |
| Designation |
chairman and md nethradhama superspeciality eye hospital |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
#256/14 kanakpura main road 7th block Jayanagar
bangalore
560082
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sri Ganesh |
| Address |
256/14 Kanakapura main road Jayanagar 7th block Bengaluru |
| 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 |
| Dr Sri Ganesh |
Nethradhama Superspeciality eye hospital |
#256/14, Kanakapura main road, Jayanagar 7th block
Bangalore
KARNATAKA |
9845129740
phacomaverick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Superspeciality eye hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H526||Other disorders of refraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
medium cone |
medium cone during smile |
| Comparator Agent |
small cone |
small cone during SMILE |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.patients with myopia with or without astigmatism
2.manifest spherical equivalent between 3-10 diopters
3.stable refraction of less than 0.50 D change in last 1 year
4.white to white diameter more than or equal to 12 mm
5.cdva of 6/6 0r better in both eyes
6.residual stroll bed thickness of 280 micron or more
7.ability to understand and willingness to sign inform consent and participate in follow up visits |
|
| ExclusionCriteria |
| Details |
1.patient not able to lie in horizontal position
2.patient not able to understand and give informed consent
3.significant dry eye or lid and adnexal disease
4.herpes viral infection
5.diabetes
6.pregnant or nursing women
7.patients with a weight of more than 135kg
8.treatment with systemic medication which influence wound healing
9.medication with the active substance isotretinoin
10.previous intraocular or corneal surgery
11.disorder of cornea
12.keratoconus
13.corneal dystrophies
14.corneal scars
15.cataract
16.glaucoma suspect
17.patients with unstable refractive error
18.anisometropia of 2D or more
19.residual stroll bed thickness less than 250 micron
20.patient who have undergone cataract surgery
21.age related macular degeneration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
clinical outcome and visual quality (time frame : pre-operative visit,1st day,15 days and 3months follow-up
uncorrected visual acuity (time frame :pre-operative,1 day,15 day & 3months follow-up)
best corrected visual acuity (time frame: 1 day , 15 day & 3months follow-up)
A lower LogMAR value indicates better visual acuity
lower OSI value indicates better visual quality |
pre-operative visit,1st day,15 day & 3 months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse events |
day 1, day 15, 3months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/01/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1 Maurice DM. The structure and transparency of the cornea. J Physiol (Lond) 1957;136:263–86.
2 Hart RW, Farrell RA. Light scattering in the cornea.J Opt Soc Am 1969;59:766–74.
3 Feuk T. On the transparency of the stroma in the mammalian cornea. IEEE Trans Biomed Eng 1970;17:186–90.
4 Cox JL, Farrell RA, Hart RWet al. The transparency of the mammalian cornea.
J Physiol (Lond) 1970;210:601–16.
5 Benedek GB. Theory of transparency of the eye. Appl Optics 1971;10:459–73.
6 Twersky V. Transparency of pair-related, random distribution of small scatterers, with applications to the cornea. J Opt Soc Am 1975;65:524–30. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present contralateral eye study would be conducted with the aim of assessing the outcomes and visual quality using medium versus small sized cone for docking during the procedure of Relex Smile with large corneal diameters for myopia correction .moreover ,to compare clinical outcomes including immediate visual quality, contrast sensitivity, aberrations,corneal biomechanics and patient satisfaction Thirty patients fulfilling the inclusion criteria will be enrolled in the study.righ and left eye of the patient will be randomised into two groups ,in one eye medium sized cone and other eye small sized cone will be used .energy parameters in both eyes will be same
Post surgery patients will be followed up on day 1 , 2 weeks and 3 months , the pre -operative investigations will be repeated during the follow up visits and adverse events will be documented and duly informed to Ethics Committee.
|