| CTRI Number |
CTRI/2024/07/070509 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Topography-Guided Treatment with the MEL Excimer Laser in Normal Virgin Eyes. |
|
Scientific Title of Study
|
Post-Market Evaluation of Topography-Guided Treatment with the MEL Excimer Laser in Normal Virgin Eyes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPAS-REF-021-01 Version 1.0 dated 08/Mar/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle
Near Shantipura circle
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle
Near Shantipura circle
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle
Near Shantipura circle
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| Carl Zeiss Meditec Inc.
5300 Central Parkway
Dublin, CA 94568, USA
|
|
|
Primary Sponsor
|
| Name |
Carl Zeiss Meditec Inc. |
| Address |
5300 Central Parkway
Dublin, CA 94568, USA
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Malaysia |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sri Ganesh |
Nethradhama Super Speciality Eye Hospital |
No 256/14, Kanakapura Main Road. 7th Block, Jayanagar, Bangalore-560070, Karnataka, India
Bangalore
KARNATAKA |
9845129470
chairman@nethradhama.org |
| Dr Krishan Prasad Kudlu |
Prasad Netralaya Super Specialty Eye Hospital |
A.J Alse Road Behind Alankar Theatre, Udupi, -576101, Karnataka, India
Udupi
KARNATAKA |
9845102334
krishprasadk73@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Nethradhama Super Speciality Eye Hospital - IEC |
Approved |
| NETRA JYOTHI INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H527||Unspecified disorder of refraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. MEL80/MEL90 excimer laser &
2. CRS-Master
|
1. The MEL is an excimer laser for the refractive surgery (LASIK and PRK)
2. Treatment planning station for MEL80/MEL 90,
Dose: NA,
Frequency: Once in study,
Duration of Therapy:06 Months.
|
| Comparator Agent |
NA |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female subjects of age between 18 to 40 years old
2. Scheduled to undergo bilateral LASIK surgery for myopia or myopic astigmatism
3. Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
4. Normal corneal topography in each eye
5. Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination
6. Preoperative corneal astigmatism less than or equal to 2 D in each eye
7. Corneal astigmatism and refractive cylinder are with 0.50 D and axis within 10°
8. Preoperative corneal higher order aberrations (HOA) RMS less than or equal to 0.4 microns in each eye
9. Preoperative whole eye higher order aberrations (HOA RMS less than or equal to 0.5 microns measured at a 6 mm pupil diameter in each eye
10. Angle kappa less than or equal to 5 degrees in each eye
11. Residual stromal thickness greater than or equal to 280 microns in each eye
12. Availability, willingness, to comply with examination follow up visits
13. Signed informed consent and data protection documents
|
|
| ExclusionCriteria |
| Details |
1. Irregular corneal astigmatism in each eye
2. Ocular surface disease in each eye
3. History of ocular surgery, ocular pathology, or other significant ocular findings that, in the investigator’s opinion, may increase the patient’s risk for corneal refractive surgery or affect potential visual outcomes in each eye
4. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
5. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in each eye
6. Clinically significant pupil abnormalities in each eye
7. Desire for monovision correction
8. Use of systemic or ocular medications that may affect visual outcomes
9. Systemic pathology that may affect the results of the study
10. Pregnancy or being treated for conditions associated with hormonal fluctuations
11. Participation in another clinical trial in the last 30 days
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuities,
Refractive outcomes,
Corneal high-order aberrations,
Patient questionnaire.
|
Preoperative, Operative, 1-day, 1-Month, and 3‑Months postoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NA |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2024 |
| 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 Yet Recruiting |
| 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
|
The clinical trial is a Post-Market Evaluation of
Topography-Guided Treatment with the MEL Excimer Laser in Normal Virgin Eyes.
Up to 75 subjects will be enrolled to achieve 60 bilaterally treated subjects
3-months postoperatively. A minimum of 10 subjects and no more than 50% of all
subjects are to be enrolled at each site.
Subjects will be screened according to the following
assessments at the preoperative visit: visual acuity testing, manifest
refraction, corneal topography, slit-lamp examination, intraocular pressure
(IOP), pupil diameter (mesopic), dilated fundus examination, keratometry,
pachymetry, wavefront aberrometry, contrast sensitivity, and patient
questionnaire. Subjects meeting all the inclusion criteria and none of the
exclusion criteria will be invited to participate in the study. Subjects who
provide written informed consent to participate in the study will be undergo
topography-guided customized ablations (centered on the corneal vertex) using
the CRS-Master and MEL80/90 excimer laser. |