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CTRI Number  CTRI/2022/09/045287 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 06/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   achieved versus predicted flap diameter using different sizes of contact glasses and their correlation with different corneal anatomical parameters in eyes undergoing lasik using visumax 800 femtosecond laser 
Scientific Title of Study   achieved versus predicted flap diameter using different sizes of contact glasses and their correlation with keratometry and q value in eyes undergoing lasik using visumax 800 FS laser 
Trial Acronym   
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  Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore,India

Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal Brar 
Designation  senior consultant in phacorefractive department and research director 
Affiliation  Nethradhama superspeciality eye hospital 
Address  Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082 Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Pai 
Designation  fellow in phacorefractive department 
Affiliation  Nethradhama superspeciality eye hospital 
Address  Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block

Bangalore
KARNATAKA
560082
India 
Phone  9724874938  
Fax    
Email  draditipai823@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama superspeciality eye hospital,256/14,kanakapura road,opp ICICI banl,7th block jayanagar bangalore-560070 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditi Pai  Nethradhama superspeciality eye hospital  Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore,India
Bangalore
KARNATAKA 		 9724874938

draditipai823@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee for research on human subjects,Nethradhama superspeciality eye hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H522||Astigmatism, (2) ICD-10 Condition: H520||Hypermetropia, (3) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  flap diameter  Based on optical zone, pupil size and white to white diameter ,different sizes of applanating contact glasses will be used and flap will be created with FS laser. predicted flap size will be compared with post operative achieved flap size and will be corelated with the corneal anatomic parameters like keratomtery and q value of the patient. Total duration of intervention for each eye will be 5-7minutes 
Intervention  Visumax 800 Femtosecond laser  visumax 800 femtosecond laser is used to create corneal flap in patients undergoing cornea based refractive correction surgery 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.myopic SE between -1 to -10D
2.hyperopic SE between +0.25 to +5D
3.Astigmatism from 0.75 to 5D 
 
ExclusionCriteria 
Details  1.keratoconus
2.pellucid marginal degeneration
3.suspect corneas
4.severe dry eyes
5.meibomian gland disease
6.glaucoma
7.retinal diseases
8.pregnancy
9.patient on immunosuppressants
10.patients with unassured follow-ups 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.flap diameter (mm)
2.flap depth
3.ease of flap seperation
4.OBL grading
5.steep keratometry(D)
6.mean keratometry(D)
7.maximum keratometry(D)
8.Q-value
9.white to white diameter(mm)
10.central corneal thickness(microns)
11.angle kappa(mm)
 		 PRE-operative
steep keratometry(D)
mean keratometry(D)
maximum keratometry(D)
Q-value
white to white diameter(mm)
central corneal thickness(microns)
angle kappa(mm)

INTRA-OPERATIVE
Flap diameter
ease of flap seperation
OBL grading

POST OPERATIVE DAY 1 AND DAY 15
Flap diameter
flap depth
steep keratometry(D)
mean keratometry(D)
maximum keratometry(D)
Q-value
white to white diameter(mm)
central corneal thickness(microns)
angle kappa(mm)
 
 
Secondary Outcome  
Outcome  TimePoints 
1.visual acuity
2.manifest refraction and spherical equivalent
3.objective scatter index
 		 pre operative
post operative day 1 and day 15 
 
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)   10/09/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Femto-flaps are recognized to have better safety, accuracy and predictability when compared to flaps created using a microkeratome. However it has been observed that the post-operative flap diameter achieved using femto-laser is slightly larger in diameter compared to what was originally planned. This may have implications, clinically. Especially while treating eyes with larger pupil size or hyperopic eyes where larger flaps are planned wherein the flap diameter may extend beyond the planned, resulting in a more peripheral cut. This may potentially result in more post-op corneal dryness due to cutting of the peripheral nerve plexus or may increase the risk of bleeding from the peripheral corneal vessels in patients using contact lenses prior to LASIK. Different mechanisms may be the cause of this disparity , chiefly the excessive pressure on the cornea while docking, significant opaque bubble layer formation or mismatch of the corneal curvature and the curvature of the contact glass. This prospective, interventional, non-randomized comparative study would thus investigate the correlation of various corneal anatomic parameters ( keratometry, Q-value, white to white diameter etc) with the post-operative flap size achieved following docking using different sizes of contact glass. The study would thus help us in elucidating the reasons for the disparity observed in predicted versus achieved flap size and the effects of using different sizes of applanating contact glasses.
The type of contact glass to be used during the surgery will be decided by the surgeon after considering the optical zone, pupil size and white to white diameter of the cornea. The recommended minimum corneal diameter for use of small contact glass will be 11.2 mm or less and for the medium contact glass will be between 11.3 to 12 mm.
 
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