CTRI/2023/11/060182 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On:
21/11/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Medical Device Surgical/Anesthesia
Study Design
Single Arm Study
Public Title of Study
This study will assess the outcome and efficacy of a new viscoelastic device which is used for protecting the corneal endothelium during cataract surgery.
Scientific Title of Study
A prospective, open-label, single-arm clinical study to evaluate the performance & safety of Eyevisc 2.4% OVD in patient undergoing cataract surgery
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DrShreyas Ramamurthy
Designation
Director
Affiliation
The Eye Foundation
Address
The Eye Foundation,
582A, DB Road, RS Puram, Coimbatore
Coimbatore TAMIL NADU 641002 India
Phone
9894231663
Fax
Email
shreyas@theeyefoundation.in
Details of Contact Person Scientific Query
Name
DrShreyas Ramamurthy
Designation
Director
Affiliation
The Eye Foundation
Address
The Eye Foundation,
582A, DB Road, RS Puram, Coimbatore
TAMIL NADU 641002 India
Phone
9894231663
Fax
Email
shreyas@theeyefoundation.in
Details of Contact Person Public Query
Name
DrShreyas Ramamurthy
Designation
Director
Affiliation
The Eye Foundation
Address
The Eye Foundation,
582A, DB Road, RS Puram, Coimbatore
1) Unilateral/Bilateral
2) Age ≥ 45 year or greater.
3) Cataract for which phacoemulsification extraction and posterior
chamber IOL implantation was planned in at least one eye of the
patient. 4) Clear intraocular media other than cataract.
5) Signed informed consent. 6) Patient who are willing to attend all the regular follow-up
examinations as per the study schedule.
7) Patients with Grade I to III cataract and used OVDs
8) Patients that have healthy eyes excluding the formation of cataract.
9) Given consent to use device related data for scientific purpose.
10) No other ocular pathology or condition and pupil dilation that was
greater than 7.0 mm
ExclusionCriteria
Details
1) Concurrent participation or participation in the last 30 days in any
other clinical trial.
2) History of previous steroid - induced IOP
3) Patient with pigment dispersion syndrome
4) Taking medications that may affect vision, IOP, or ease of cataract
surgery (e.g., Flomax, glaucoma medications, etc.)
5) Acute or chronic disease or illness that would increase risk or
confound study results (e.g., diabetes mellitus,
immunocompromised, etc.).
6) Uncontrolled systemic or ocular disease.
7) Previous intra ocular or corneal surgery or history of ocular trauma. 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial
dystrophies).
9) Known pathology that may affect visual acuity; particularly retinal
changes that affect vision (e.g., macular degeneration, cystoid
macular edema, diabetic retinopathy, etc.).
10) Any visual disorder predicted to cause future acuity loss to a level
of 0.3 LogMAR or worse.
11) Pseudoexfoliation
12) Ocular hypertension (>22 mm Hg) or glaucomatous changes in the
optic nerve.
13) Endothelial cell counts lower than 1500 cells/mm2 preoperatively
(based on the lowest value of three cell counts performed by
technician at investigative site).
14) Patient is pregnant, planned to become pregnant, lactating or had
another condition associated with the fluctuation of hormones that
could lead to refractive changes.
15) Vulnerable subject.
16) Black, Brunescent, traumatic or subluxated cataract.
17) Patient who had Glaucoma, Pseudo exfoliation Syndrome with Iris
atrophy, uveitis, Proliferative diabetic retinopathy at the time of
surgery (Random blood sugar level more than 140 mg/dl).
18) A history of chronic or recurrent inflammatory eye disease (e.g.
iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis).
19) Intraocular pressure (IOP) higher than 24 mm Hg
20) Surgery of the contralateral eye performed or planned within a
period of 7 days before or after the surgery of the studied eye
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Percentage of participants with postoperative intraocular pressure
of at least 30 mm Hg [Time Frame: 3 Months]
2. Percent change in Mean Epithelial Cell Density (ECD) (Safety
end point) [Time Frame: 3 Months]
1. Percentage of participants with postoperative intraocular pressure
of at least 30 mm Hg [Time Frame: 3 Months]
2. Percent change in Mean Epithelial Cell Density (ECD) (Safety
end point) [Time Frame: 3 Months]
Secondary Outcome
Outcome
TimePoints
1. Change in Corneal thickness
2. Intraocular Inflammation with Grade of Inflammation
3. Corneal Clarity
4. CV in cell size
5. Cell area
6. Number of cell analyzed
7. Cell Hexagonality
8. Adverse Event/complication
Baseline & 3 months
Target Sample Size
Total Sample Size="131" Sample Size from India="131" 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)
01/12/2023
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="6" Days="15"
Recruitment Status of Trial (Global)
Not Applicable
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
3 SYNOPSIS
Title of Study
A prospective, open-label, single arm clinical study to evaluate the
safety & performance of Eyevisc 2.4% OVD in patient undergoing
cataract surgery.
Protocol No, Version, Date BVCPL-HPMC-2023-01, 1.0, 24-July-2023
Study Device
EYEVISCâ„¢ 2.4% (Hydroxypropyl Methylcellulose 2.4 %) (Biotech
Vision Care Pvt. Ltd.)
Study Design
This study is a prospective, open-label, single arm clinical study to
evaluate the safety & performance of Eyevisc 2.4% OVD in patient
undergoing cataract surgery.
Number of patients 131 eyes
Number of Centers 1 Center
Duration of clinical
Study 9 Month (6 Month for enrolment and 3 month for follow-up)
Objectives
Primary Objective: ï‚· To evaluate the performance of EYEVISC 2.4% in patient
undergoing cataract surgery.
Secondary Objectives: ï‚· To evaluate the safety of EYEVISC 2.4% in patient undergoing
cataract surgery.
Study Endpoints
Primary Endpoint
1. Percentage of participants with postoperative intraocular pressure
of at least 30 mm Hg [Time Frame: 3 Months]
2. Percent change in Mean Epithelial Cell Density (ECD) (Safety
end point) [Time Frame: 3 Months]
Secondary Endpoint
1. Grade of Cataract
2. Investigator Reported Space Maintenance
3. Total Phaco time
4. Effective Phaco time
5. Average Phaco power 6. Vacuum
7. Change in Corneal thickness
8. Intraocular Inflammation with Grade of Inflammation
9. Corneal Clarity
10. CV in cell size
11. Cell area
12. Number of cell analyzed
13. Cell Hexagonality
14. Adverse Event/complication
Clinical Parameter
1) Intraocular Pressure [Time frame: Pre-operative, 8 hours, 24
hours, 7 days, 30 days and 90 days post-operative] Intraocular
pressure will be measured by Goldmann Applanation
Tonometry in mmHg.
2) Corneal Endothelium Cell Density [Time Frame: Pre- operative, Post-operative 7 days, 30 days and 90
days] Endothelial cell count (cell/mm2
) will be performed by
counting of cells on photographic image of endothelium taken
by Specular Microscope (cell/mm²). 3) Intraocular Inflammation with Grade of
Inflammation [Time Frame: Pre-operative, post-operative 24
hours, 7 days, 30 days and 90 days] Measurement performed
by slit-lamp bio microscopy. Grading of Inflammation will be
done based on Aqueous cells and flares as per Standardization
Uveitis Nomenclature (SUN):
Grade Cells* Flare
0 None None
0.5 + 1-5 cells in
field --- 1 + 6-15 cells Faint
2 + 16-25 cells Moderate (Iris and lens details are
clear)
3 + 26-50 cells Marked (Iris and lens details are hazy)
4 + >50 cells Intense (Fibrin or plasmoid aqueous)
* Field size should be 1 mm by 1 mm slit beam. The presence or absence of hypopyon
should be noted separately in addition to the cellular activity grade. 4) Corneal Thickness [Time Frame: Pre-operative, Post- operative 7 days, 30 days and 90 days] Change in corneal
thickness will be measured in micrometre (µm). Measurement
performed by SIRIUS topographer.
5) Visual Acuity [Time Frame: Pre-operative, Post-operative 7
days, 30 days and 90 days] Visual Acuity (VA) is 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.
a. Uncorrected visual acuity (UCVA)
b. Best Corrected visual acuity (BCVA)
6) Corneal Clarity [Time Frame: Pre-operative, Post-operative
8 hours, 24 hours, 7 days, 30 days and 90 days] It will be
evaluated by slit-lamp bio microscope. Grading of corneal
clarity on the basis of corneal haze as following;
Grade Detail
0 No corneal haze
1 Iris details visible
2 Pupillary margin visible, iris details not visible
3 Pupillary margin not visible
4 Cornea totally opaque
7) Cell Area [Time Frame: Pre-operative, Post-operative 90
days] It will be measured by Specular Microscope
8) Cell Hexagonality [Time Frame: Pre-operative, Post- operative 90 days] It will be measured by Specular
Microscope
9) Slit Lamp Examination [Time Frame: Pre-operative, Post- operative 8 hours, 24 hours, 7 days, 30 days and 90 days] ï‚· Cells ï‚· Corneal Clarity
ï‚· Fibrin (grading from 0-none to 4-severe) in anterior
chamber by slit lamp examination
ï‚· Flare ï‚· Iritis ï‚· Lens Clarity
Safety Endpoint:
1) Adverse Events [Time Frame: Intra-operative visit, Post- operative 8-hours, 24 hours, 7 days, 30 days, 90 days and as
and when occur]
Parameters to be
obtained during
intra-operative
procedure
1) Investigator Reported Space Maintenance: Maintenance of the
anterior chamber/dome during cataract surgery. Space
maintenance was reported during Capsulorhexis, Hydro- dissection, Phacoemulsification, and IOL insertion. This will be
rated by the surgeon on of the following category: ï€ Full Chamber Maintained ï€ Working Space Maintained ï€ Shallow
ï€ Flat
2) OVD residing time in Anterior Chamber: It will be reported in
Minutes
3) Removal time of OVD: It will be reported in Seconds
4) Total Phaco time: It will be reported in Seconds
5) Effective Phaco time: It will be reported in Seconds
6) Average Phaco power: It will be reported in percentage
7) Vacuum: It will be reported in mmHg
8) Ease of removal: It will be rated in following parameters based
on investigator’s experience. ï€ Excellent ï€ Very Good ï€ Good
- Needs Improvement
Eligibility Criteria
Inclusion Criteria:
1) Unilateral/Bilateral
2) Age ≥ 45 year or greater. 3) Cataract for which phacoemulsification extraction and posterior
chamber IOL implantation was planned in at least one eye of the
patient. 4) Clear intraocular media other than cataract.
5) Signed informed consent. 6) Patient who are willing to attend all the regular follow-up
examinations as per the study schedule.
7) Patients with Grade I to III cataract and used OVDs
8) Patients that have healthy eyes excluding the formation of cataract.
9) Given consent to use device related data for scientific purpose.
10) No other ocular pathology or condition and pupil dilation that was
greater than 7.0 mm
Exclusion Criteria:
1) Concurrent participation or participation in the last 30 days in any
other clinical trial.
2) History of previous steroid - induced IOP
3) Patient with pigment dispersion syndrome
4) Taking medications that may affect vision, IOP, or ease of cataract
surgery (e.g., Flomax, glaucoma medications, etc.)
5) Acute or chronic disease or illness that would increase risk or
confound study results (e.g., diabetes mellitus,
immunocompromised, etc.).
6) Uncontrolled systemic or ocular disease.
7) Previous intra ocular or corneal surgery or history of ocular trauma. 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial
dystrophies).
9) Known pathology that may affect visual acuity; particularly retinal
changes that affect vision (e.g., macular degeneration, cystoid
macular edema, diabetic retinopathy, etc.).
10) Any visual disorder predicted to cause future acuity loss to a level
of 0.3 LogMAR or worse. Pseudoexfoliation
12) Ocular hypertension (>22 mm Hg) or glaucomatous changes in the
optic nerve.
13) Endothelial cell counts lower than 1500 cells/mm2 preoperatively
(based on the lowest value of three cell counts performed by
technician at investigative site).
14) Patient is pregnant, planned to become pregnant, lactating or had
another condition associated with the fluctuation of hormones that
could lead to refractive changes.
15) Vulnerable subject.
16) Black, Brunescent, traumatic or subluxated cataract.
17) Patient who had Glaucoma, Pseudo exfoliation Syndrome with Iris
atrophy, uveitis, Proliferative diabetic retinopathy at the time of
surgery (Random blood sugar level more than 140 mg/dl).
18) A history of chronic or recurrent inflammatory eye disease (e.g.
iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis).
19) Intraocular pressure (IOP) higher than 24 mm Hg
20) Surgery of the contralateral eye performed or planned within a
period of 7 days before or after the surgery of the studied eye
Rational and
justification
Justification for
study design
It is a prospective, open-label, single-arm, post market clinical study
where in only one HPMC OVD will be used during the surgical
procedure, the clinical data obtained will be statistically analysed as per
defined ISO standard and will be reported. The rationale of conducting
this study is to prospectively evaluate the performance, safety and
efficacy of Eyevisc in patients undergoing routine cataract surgery.
A Rationale for the Choice of the control OVD
Not applicable as it is single arm study.
Follow-up schedule
 Pre-operative Visit/Screening Visit  Surgery Visit/Intra-operative Visit  Post-operative 8 hours ± 2 hours  Post-operative 24 hours ± 4 hours  Post-operative 7 Days ± 2 days  Post-operative 30 days ± 7 days  Post-operative 90 days ± 14 days
Apart from this follow-up schedule, if patient turned up for any
additional unscheduled visit to clinic then data for that particular visit
will be documented in the Case Report Form (CRF) in appropriate
section.
Statistical Analysis
The continuous data will be summarized using descriptive statistics
(number of subjects (n), mean, standard deviation (SD), median,
minimum and maximum). Categorical data will be summarized
frequency count (n) and percentages (%). All statistical tests will be
conducted at the 5% significance level, unless indicated otherwise.
Primary Endpoint:
The EYEVISC 2.4% in terms of the incidence of IOP observations
above 30 mmHg will be summarized using descriptive statistics at each
visit.
Other parameters analysis:
Intraocular Pressure, Corneal Endothelium Cell, Intraocular
Inflammation with Grade of Inflammation, Corneal Thickness, Visual
acuity, Corneal clarity, Cell Area, Cell Hexagonality and Slit lamp
examination will be summarized using descriptive statistics. A detailed description of the analysis will be provided in statistical
analysis plan.
Ethical
Consideration
The clinical Study plan, informed consent form and other study related
documents must be submitted to the appropriate Ethics Committee (EC)
and written approval must be obtained. The investigator will not make
any change in the research without EC approval, except when necessary
to eliminate immediate hazards to human patients. The Investigator will
promptly report to the EC proposed changes and all unanticipated
problems involving risks to human patients or others. These amendments involving significant risk or changes requiring EC
approval and written documentation of this approval must be submitted
by the investigator before implementation except in case of emergency
where the investigator may implement the amendments and then inform
the EC as soon as possible.