| CTRI Number |
CTRI/2023/05/052980 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial comparing corneal morphological (changes in structure, thickness) and biomechanical (corneal strength changes) Outcomes of Femtosecond laser assisted LASIK refractive surgery with two machines namely Visumax -MEL90 and Wavelight FS200-EX500 Lasers |
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Scientific Title of Study
|
Comparison of Morphological and Biomechanical Outcomes of FS-LASIK with Visumax-MEL90 and Wavelight FS200-EX500 Lasers- a Randomised Controlled Trial |
| 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 Jeewan Singh Titiyal |
| Designation |
Professor and Chief, Department of Ophthalmology |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi- 110029
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
titiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeewan Singh Titiyal |
| Designation |
Professor and Chief, Department of Ophthalmology |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi- 110029
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
titiyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatesh Antalmarad |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi- 110029
South
DELHI
110029
India |
| Phone |
8050475691 |
| Fax |
|
| Email |
venkatesh.a126@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences, Sri Aurobindo marg, Ansari nagar, New Delhi-110029 |
|
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Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
All India Institute of Medical Sciences Sri Aurobindo Marg Ansari Nagar East New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeewan Singh Titiyal |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, NEW DELHI |
4th floor, room 491, 4th floor, Department of Ophthalmology Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi- 110029
South
DELHI |
01126593146
titiyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS,New Delhi |
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: H521||Myopia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FS- LASIK with Wavelight FS200 |
The laser has a high suction pressure of 80-100 mmHg with a longer suction time of 35-40 seconds. It creates corneal flap by applanation method by making cornea flat by raster pattern. |
| Intervention |
FS-LASIK with Visumax MEL90 |
The laser system has a low suction pressure of about 35mmHg with a suction time is about 30 seconds. It Creates corneal flap by acurvation method by maintaining corneal curvature by spiral pattern. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients undergoing FS-LASIK for myopia or myopic astigmatism
2)Stable refractive error for >1 year
3)Minimum calculated RSBT- 300 microns
4)Patients willing to give informed consent
5)Patients willing for follow up
|
|
| ExclusionCriteria |
| Details |
1)Progressive or unstable myopia
2)External ocular disease/ keratoconus (including forme-fruste)/ Pellucid marginal degeneration.
3)Diabetes, connective tissue disease, Atopy; pregnant or nursing patients.
4)Corticosteriods or antimetabolites use
5)Previous corneal surgery/ Re-treatment, not willing to follow up.
6)Soft contact lens use in past 2 weeks or rigid gas permeable contact lens wear in past 4 weeks. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Central Flap Thickness |
Day 1, 1 week, 1 month, 3 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)Corneal Biomechanical outcomes (Including DA, A length, A velocity, CBI-LVC index)
2)Anterior chamber angle parameters (ACD, ARA, TIA, TISA, AOD)
3)Posterior Segment Changes (Bursa premacularis, Area of Martigiani, RNFL thickness , GCL thickness, CMT)
4)Flap shape, regularity, accuracy
5)Visual Quality (HOAs, Strehl Ratio, MTF, PSF)
6)Suction time |
Day 1, 1 week, 1 month, 3 months |
|
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Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
31/05/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NOT YET |
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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
|
Corneal laser ablative procedures are the most commonly practiced refractive surgery. Femtosecond laser is an infrared laser (1053nm) that works by producing photodisruption or photoionisation of optically transparent tissue such as Cornea. LASIK surgery involves creation of corneal flaps done by either Microkeratome(produces meniscus shape flaps) or Femtosecond Laser (produce planar flaps) followed by Excimer Laser Ablation. Femtosecond laser has gained superiority over microkeratome for creating corneal flaps due to more planar architecture , greater precision in flap diameter and thickness, uniform flap thickness across the flap diameter, customisable by surgeon to programme angulation of flap periphery. Two FS lasers available in our Centre are Zeiss Visumax MEL-90 and Alcon Wavelight FS200. Zeiss Visumax laser system has a low suction pressure of about 35mmHg with a suction time of about 30 seconds. It Creates corneal flap by acurvation method by maintaining corneal curvature by spiral pattern. Alcon Wavelight FS200 laser system has a high suction pressure (80-100 mmHg) with a longer suction time (35-40 seconds). It creates corneal flap by applanation method by making cornea flat by raster pattern. The difference in suction pressure and suction time during femtosecond laser application for flap creation may also produce anterior and posterior segment changes.
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