| CTRI Number |
CTRI/2023/03/050397 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| 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
|
A comparative clinical study to evaluate the safety and performance of capsular tension ring. |
|
Scientific Title of Study
|
A prospective, controlled randomized, comparative, single center, clinical study to evaluate performance and safety of implanted Capsular Tension Ring (CTR) and CTR delivery system. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sartaj Singh Grewal |
| Designation |
Consultant |
| Affiliation |
Grewal Eye Institute |
| Address |
Room No. 201, Level-1,SCO: 168-169, Sector 9C, Chandigarh - 160 009 (INDIA)
Chandigarh
CHANDIGARH
160009
India |
| Phone |
9779716169 |
| Fax |
|
| Email |
sartajg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sartaj Singh Grewal |
| Designation |
Consultant |
| Affiliation |
Grewal Eye Institute |
| Address |
Room No. 201, Level-1, SCO: 168-169, Sector 9C, Chandigarh - 160 009 (INDIA)
Chandigarh
CHANDIGARH
160009
India |
| Phone |
9779716169 |
| Fax |
|
| Email |
sartajg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sartaj Singh Grewal |
| Designation |
Consultant |
| Affiliation |
Grewal Eye Institute |
| Address |
Room No. 201, Level-1, SCO: 168-169, Sector 9C, Chandigarh - 160 009 (INDIA)
Chandigarh
CHANDIGARH
160009
India |
| Phone |
9779716169 |
| Fax |
|
| Email |
sartajg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Grewal Eye Institute |
| Address |
Sco-168-169, Sector 9C, Chandigarh - 160009 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sartaj Singh |
Grewal eye institute |
Room No. 201, Level-1, SCO 168-169, Sector 9C
Chandigarh
CHANDIGARH |
9779716169
sartajg@gmail.com |
| Dr Jagdeesh Kumar Reddy |
Sankara eye Hospital |
Clinical Research Dept, Innovation centre, 3rd Floor, Main buliding, Sankara Eye Hospital, 16 A, Sathy Road, Sivanandapuram, Coimbatore- PIN 641035, Tamil Nadu.
Coimbatore
TAMIL NADU |
8838340385
reddyjk@yahoo.com |
| Dr Uday Gajiwala |
Tejas eye Hospital |
Office number 4 clinical
trial department,
Ground floor, Tejas Eye
Hospital Run by
Divyajyoti Trust Suthar
Falia, Opp. Hanuman
Temple, At & Po.
Mandvi, Dist. : Surat -
394160
Surat
GUJARAT
Surat
GUJARAT |
9426125947
divyajyoti.icare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Indus International Hospital-Institutional Ethics Committee |
Approved |
| Institutional ethics committee divyajoti trust tejas eye hospital |
Approved |
| Sankara eye hospital instituional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOVISION CTR (Capsular Tension Ring)
A. CTR implantation with reusable delivery system
Models: CTR11B, CTR12B, CTR13B, CTR14B |
Duration of therapy as per below:
 Pre-operative Visit/ Screening Visit
 Intra-operative/ Surgery Visit
 Post-operative 1 Day
 Post-operative 15 Days ± 2 Days
 Post-operative 90 Days ± 07 Days |
| Comparator Agent |
Preloaded CTR implantation
Models: PLCTR11B, PLCTR12B, PLCTR13B, PLCTR14B |
Duration of therapy as per below:
 Pre-operative Visit/ Screening Visit
 Intra-operative/ Surgery Visit
 Post-operative 1 Day
 Post-operative 15 Days ± 2 Days
 Post-operative 90 Days ± 07 Days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients older than 12 years
2. Normal fundus examination
3. Patients for whom phacoemulsification is required of cataract
surgery
4. Patients with axial length >28 mm, or more than 3 months had
passed since Pars plana vitrectomy (PPV)
5. Patients with weak zonules along with any of this following
conditions
Inadequate zonular support
Patients with the pseudo-exfoliation syndrome
Trauma causing zonular dialysis
Phacodonesis
6. Patients who are eligible for phacoemulsification alone or
with CTR implants
7. Patients who are eligible for phacoemulsification alone or
with CTR implants
8. Patient willing to participate and sign informed consent forms.
9. 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. Presence of a torn or compromised capsular
bag or significant, progressive
pseudoexfoliation
2. Patients with retinitis pigmentosa,
trauma, other intraocular surgeries than
PPV, or connective tissue disorders
3. Patients with chronic uveitis
4. Patients with progressive eye disease
(e.g. diabetic retinopathy, uncontrolled
glaucoma)
5. Patients with preoperative complications
prior to cataract surgery (e.g. vitreous
body prolapse, haemorrhage)
6. Patients with perforated or damaged
capsules
7. Patients with zonular damage larger than 4
clock hours
8. Zonular rupture >90º
9. Pregnancy (as stated by patient) and
lactation
10. Patients with concurrent participation in
another drug or medical device clinical
study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) Refraction - Refractive prediction error - Measured as subjective refraction. Both spherical and astigmatism shall be measured by using phoropter. |
Time Frame: Pre-operative, 90 Days Post- operative surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Visual Acuity-UDVA - The visual acuity upto 90 ± 7 days post- operative surgery, measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Visual acuity measured by ETDRS chart.
2) Visual Acuity- BCDVA - The visual acuity upto 90 ± 7 days post- operative surgery, measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Visual acuity measured by ETDRS chart.
3) IOL Tilt
• IOL Tilt - Measured by Pentacam
4) IOL Decentration -
• IOL Decentration - Measured by Pentacam
|
1) Visual Acuity-UDVA -Time Frame: Pre-operative, 90 Days Post- operative surgery
2) Visual Acuity- BCDVA -Time Frame: Pre-operative, 90 Days Post- operative surgery
3) IOL Tilt and 4) IOL Decentration - Time Frame: 15 Days Post- operative surgery, 90 Days Post- operative surgery
|
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
15/03/2023 |
| 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="0"
Months="8"
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
|
Title
of Study: A prospective,
controlled randomized, comparative, single
center, clinical study to evaluate performance and safety
of implanted Capsular Tension Ring (CTR) and CTR delivery system.
Objectives: Primary Objectives:
To evaluate the performance of Capsular Tension Ring
(CTR) against controlled group (without CTR) to check clinical outcome of
refractive prediction error.
Secondary
Objectives:
For Capsular Tension Ring:
·
To evaluate
the performance of Capsular Tension Ring against controlled group (without CTR)
to check clinical outcome of visual acuity.
·
To evaluate
safety of Capsular Tension Ring implanted group and controlled group (without
CTR).
For
Delivery System:
To check the safety and performance of two delivery systems for CTR
implant. |