| CTRI Number |
CTRI/2021/12/038930 [Registered on: 27/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This is a comparative clinical trial of two phakic toric lens in patient with Near-sightedness and cylindrical refractive error. |
|
Scientific Title of Study
|
A prospective, randomized clinical study of two phakictoric implantablelenses to outcome in in patients with moderate to high myopia and astimatism. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BTVCPL-PHAKICTORIC-2019-13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and Managing director, Netradhama Superspeciality Eye Hospital |
| Affiliation |
Netradhama Superspeciality Eye Hospital |
| Address |
Netradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road
7th Block, Jayanagar, Bangalore-560 082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Devendrapalsingh Khalsa |
| Designation |
Head – Marketing & Clinical Affairs |
| Affiliation |
BIOTECH VISION CARE PVT. LTD |
| Address |
BIOTECH VISION CARE PVT. LTD
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road,
Ahmedabad - 380 058, Gujarat - India.
Ahmadabad
GUJARAT
380058
India |
| Phone |
|
| Fax |
|
| Email |
devendra@biotechhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Devendrapalsingh Khalsa |
| Designation |
Head – Marketing & Clinical Affairs |
| Affiliation |
BIOTECH VISION CARE PVT. LTD |
| Address |
BIOTECH VISION CARE PVT. LTD
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road,
Ahmedabad - 380 058, Gujarat - India.
Ahmadabad
GUJARAT
380058
India |
| Phone |
|
| Fax |
|
| Email |
devendra@biotechhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Biotech Healthcare Holdings GmbH |
|
|
Primary Sponsor
|
| Name |
Biotech Healthcare Holdings GmbH |
| Address |
Obergrundsrasse 17,
6002 Luzern,
Switzerland |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Germany
Turkey |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preethi Naveen |
Dr. Agarwal Eye Hospital |
2nd Floor, Clinical research department,No.222, TTK Road, Alwarpet, Near Raj Park Hotel, Chennai, Tamil Nadu 600018.
Chennai
TAMIL NADU |
9940042812
drpreethinaveen82@gmail.com |
| Dr Sri Ganesh |
Netradhama Superspeciality Eye Hospital |
BlOCK 2 PHACO REFRACTIVE DEPARTMENT
256/14, Kanakapura Main Road
7th Block, Jayanagar,
Bangalore-560 082
Bangalore
KARNATAKA |
9845195898
phacomaverick@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Disha eye hospitals ethics committee |
Approved |
| Dr. Agarwal eye hospital- IEC |
Approved |
| Ethics Committee, Nethradhama Super Speciality Eye Hospital, (ECR/218/Indt/KA/2014 ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EYECRYLâ„¢ Phakic Toric |
Investigational product is Phakic toric lens which are surgically placed either in
anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. |
| Comparator Agent |
Visian® Toric ICL |
Comparator product is Phakic Toric intraocular lens which are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients 21 years old or older.
2. Calculated IOL Power is within the range of the investigational IOLs
3. Corneal Cylindrical error within the range defined in the clinical investigation plan
4. Subject has monocular UCVA 0.5 LogMAR or worse
5. Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
6. Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria:
a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
b. Two refractions were performed at least 7 days apart.
7. Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
8. Expected dilated pupil size at least large enough to visualize the axis marking.
9. Patients willing to attend all follow-up appointments
10. Patients must sign and be given a copy of the written Informed Consent form
11. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. |
|
| ExclusionCriteria |
| Details |
1. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
2. Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
3. Subject with ocular condition that may predispose the subject to future complications
4. Subject with previous intraocular or corneal surgery
5. Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
6. Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
7. Other condition associated with fluctuation of hormones
8. ACD measured from the endothelium lower than 2.8 mm
9. Concurrent participation in another drug or device evaluation.
10. Any cataract of any grade
11. Coefficient of variation of endothelial cell area >0.45
12. Percent Hexagonality of endothelial cell shape ≤ 45%
13. Monocular subject
14. Vulnerable subjects |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. |
Post-operative 1 Day
Post-operative 7 Days ± 2 Days
Post-operative 1 Month ± 7 Days
Post-operative 3 Month ± 7 Days
Post-operative 6 Month ± 14 Days
Post-operative 12 Month ± 30 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism |
Post-operative 1 Day
Post-operative 7 Days ± 2 Days
Post-operative 1 Month ± 7 Days
Post-operative 3 Month ± 7 Days
Post-operative 6 Month ± 14 Days
Post-operative 12 Month ± 30 Days
|
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="20"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Product details: Eyecryl Phakic Toric Intra Ocular Lens (IOLs) is a monofocal hydrophilic acrylic foldable single-piece posterior chamber intraocular lens designed to be surgically implanted into the posterior chamber of the eye in ciliary sulcus in front of natural crystalline lens for correction or reduction of myopia and myopia with astigmatism.
This global phase IV study will compare two phakic toric implantable lenses in patients with moderate to high myopia and astigmatism. Investigational product for the study is Eyecryl Phakic Toric (Hydrophilic Acrylic Foldable Phakic Toric IOL) manufactured by Biotech Vision Care Pvt Ltd. and comparator product is Visian Toric ICL of STAAR Surgical Company. Objective of study is to compare the efficacy and the residual refractive error of EYECRYL Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism and following efficacy and safety parameters will be measured Efficacy Parameters: 1. Rotational Stability 2. Visual Acuity 3. Vault 4. IOP 5. Corneal Thickness 6.Subjective refraction 7. Spherical equivalent 8. Astigmatism 9. Endothelial cell count 10. Cell hexogonality 11. CV in cell size 12. IOL discoloration 13. IOL tilt 14. IOL decentration 15. Ophthalmoscopy 16. Slit lamp examination-Fundus visualization, Corneal status, sign of inflammation, pupillary block, status of anterior and posterior capsule, IOL opacity
Safety Parameters: 1.Cystoid macular oedema 2.Hypopyon 3.Endophthalmitis 4.Lens dislocation 5.Pupillary Block 6.Retinal Detachment 7.Secondary Surgical intervention 8.Corneal stroma oedema 9.Raised IOP requiring treatment |