| CTRI Number |
CTRI/2023/04/051897 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical trial to ensure the safety and efficacy of Phakic intraocular lenses in high myopic patients |
|
Scientific Title of Study
|
To assess the safety and efficacy of posterior chamber phakic intraocular lens (PCPIOL) in patients with high myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Ravindran |
| Designation |
Cheif Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital
Paediatric Ophthalmology and Adult strabismus
Room number 114
Ground floor Paediatric OPD block
272 SN High Road
Vannarpettai
Tirunelveli
TAMIL NADU
627001
India |
| Phone |
04624356100 |
| Fax |
|
| Email |
drmeenakshi@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Ravindran |
| Designation |
Cheif Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital
Paediatric Ophthalmology and Adult strabismus
Room number 114
Ground floor Paediatric OPD block
272 SN High Road
Vannarpettai
Tirunelveli
TAMIL NADU
627001
India |
| Phone |
04624356100 |
| Fax |
|
| Email |
drmeenakshi@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Ravindran |
| Designation |
Cheif Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital
Paediatric Ophthalmology and Adult strabismus
Room number 114
Ground floor Paediatric OPD block
272 SN High Road
Vannarpettai
Tirunelveli
TAMIL NADU
627001
India |
| Phone |
04624356100 |
| Fax |
|
| Email |
drmeenakshi@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aurolab
No 1 Sivagangai Main Road Veerapanchan
Madurai 625020 |
|
|
Primary Sponsor
|
| Name |
Aurolab |
| Address |
No 1 Sivagangai Main Road
Veerapanchan
Madurai |
| Type of Sponsor |
Other [ophthalmic and pharmaceutical manufacturing industry] |
|
|
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 Meenakshi |
Aravind Eye Hospital |
Paediatric OPD
Ground floor Room no 114
272 SN High Road
Vannarapettai
Tirunelveli
TAMIL NADU |
04624356100
drmeenakshi@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H55-H57||Other disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phakic intraocular lens |
Phakic intraocular lens is an innovative emerging technology with an optical design intended to correct widest range of myopia (nearsightedness) hyperopia (farsightedness) and astigmatism (cylinder power) |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Adults of > 21 years
b) Stable refraction atleast for 1 year
c) Myopia and Myopic astigmatism less than 1 D of corneal astigmatism
d) Clear intraocular media
e) Intraocular pressure of <20mmHg
f) Anterior chamber depth of atleast 2.8 mm and angle<33 degree (from pentacam)
g) Endothelial cell count >2500 cells/mm2
h) Normal posterior segment
i) AS OCT (Open angles)
j) Abnormal elevation and curvature maps not fit for corneal refractive surgery.
k) understand and willing to participate in the study for 2 years of follow up period
l) No systemic illness |
|
| ExclusionCriteria |
| Details |
a) Participation in any other drug or device clinical trial within 90 days prior to enrolling in this study and/or during study participation
b) corneal pathologic conditions like degenerations and dystrophies and keratoconus
c) Evidence of any lens opacity or developing cataract, pseudoexfoliation or pigmentory dispersion
d) History of glaucoma and uveitis
e) Previous history of ocular diseases
f) History of any intraocular or corneal surgery in either eye (including LASIK PRK LRI etc)
g) Anterior chamber depth <2.8 mm and angle <33 degree
h) Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Uncorrected visual acuity
b) Best corrected visual acuity
c) Intraocular Pressure
d) Endothelial cell count
e) Post operative inflammation |
day 1 one month
three months
six months
12 months
18 months
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
visual acuity
Post operative complications
Contrast sensitivity |
24 months |
|
|
Target Sample Size
|
Total Sample Size="9"
Sample Size from India="9"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The most commonly used method to correct the refraction error is LASIK But LASIK cant be done for patients having irregular and thin corneas. For those with thin or abnormal corneas Keratoconus and dry eye, phakic IOL is an excellent alternative to laser eye surgery. A Phakic IOL is an innovative emerging technology with an optical design intended to correct widest range of myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (Cylinder power). ICL procedures are being used on highly nearsighted and farsighted patients who may not be candidates for the more common laser procedures such as LASI, LASEK and PRK. Aurolab has developed zero aberration aspheric phakic foldable intraocular lens to correct low to high myopic refraction error in patients. This new technique is similar to cataract surgery, but the natural lens remains in place. So the eye’s natural focusing ability is preserved.
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