To evaluate and compare the performance & safety of two different viscoelastic devices in patient undergoing cataract surgery.
- Conditions
- Age-related nuclear cataract,
- Registration Number
- CTRI/2023/03/050364
- Lead Sponsor
- Biotech Ophthalmics Pvt Ltd
- Brief Summary
SYNOPSIS
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Title of Study
Prospective, randomized, comparative clinical investigation to evaluateand compare the performance & safety of two different OVDs in patientundergoing cataract surgery.
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Protocol No,Version, Date
BIOHYALURPLUS-2022-02, 1.0, 04-Oct-2022
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Study Devices
Sodium Hyaluronate ophthalmic viscosurgical device
1. Bio-Hyalur Plus (Sodium Hyaluronate 1.4%)
2. Protectalon (Sodium Hyaluronate 1.4%)
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Study Design
This study is a Prospective, randomized, comparative clinicalinvestigation to evaluate and compare the performance & safety of twodifferent OVDs in patient undergoing cataract surgery. Total 140subjects will be included in study.
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Number of patients
The sample size has been calculated by considering the primaryendpoint, in terms of the incidence of IOP observations <30 mmHg is98%. Assuming non-inferiority margin of 10% with allocation ratio of1:1 a sample size of 112 Eyes (i.e. 56:56) are required at 85% power,with 0.05% level of significance. Considering the drop-out rate up to20%, total 140 (70:70) patients/eyes will be required to be enrolled inthe study.
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Number of Centers
1 Center
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Duration of clinicalinvestigation
12 Month (9 Month for enrolment and 3 month for follow-up)
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Objectives
Primary Objective: To evaluate and compare the performance of Bio-Hyalur Plus against Protectalon 1.4% in patient undergoing cataractsurgery.
Secondary Objectives: To evaluate and compare the safety of Bio-Hyalur Plus against Protectalon 1.4% in patient undergoing cataractsurgery.
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Confidential and Proprietary
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Study Parameter
1. 1) Intraocularpressure[Timeframe:Pre-operative,8hours,24hours, 7 days, 30 days and 90 days post-operative] -Intraocular pressure will be measured by GoldmannApplanation Tonometry in mmHg.
2. 2) Changes in cell density of the corneal endothelium: [TimeFrame: Pre-operative, and 90 day post-operative]- Endothelial cell count (cell/mm2) performed by counting ofcells on photographic image of endothelium taken by specularmicroscope in cell/mm2.
3. 3) Intraocular Inflammation with Grade ofInflammation [Time Frame: Pre-operative, 24 hours, 7 day,30 day and 90 day post-operative] - Measurement performedby slit-lamp bio microscopy. Grading of Inflammation will bedone based on Aqueous cells and flares as per StandardizationUveitis Nomenclature (SUN);
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Grade
Cells\*
Flare
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0
None
None
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0.5 +
1-5 cells in field
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1+
6-15 cells
Faint
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2+
16-25 cells
Moderate (Iris and lens details areclear)
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3+
26-50 cells
Marked (Iris and lens details arehazy)
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4+
> 50 cells
Intense (Fibrin or plasmoid aqueous)
\* Field size should be 1 mm by 1 mm slit beam. The presence or absence of hypopyonshould be noted separately in addition to the cellular activity grade.
4. 4) Cornealthickness(μm)[TimeFrame:Pre-operative,7day,30 day and 90 day post-operative]- Change in cornealthickness will be measured in micrometre. Measurementperformed by SIRIUS topographer.
5. 5) VisualAcuity[TimeFrame:Pre-operative,30dayand90daypost-operative] - Visual Acuity (VA) is measured inLogMAR. LogMAR is the "logarithm of the minimum angle
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of resolution". A lower LogMAR value indicates better visual
acuity. Visual acuity measured by ETDRS chart.
6. 6) Uncorrecteddistancevisualacuity(UDVA)
7. 7) Correcteddistancevisualacuity(CDVA)
8. 8) Corneal Clarity [Time Frame: Pre-operative, 8 hours, 24
hour, 7 day, 30 day and 90 day post-operative] - It will beevaluated by slit-lamp bio microscope. Grading of cornealclarity on the basis of corneal haze as following;
Grade Detail
0. 0 No corneal haze
1. 1 Iris details visible
2. 2 Pupillary margin visible, iris details not visible
3. 3 Pupillary margin not visible
4. 4 Cornea totally opaque
9) CentralCornealendothelialcelldensity:[TimeFrame:Pre-operative, and 90 day post-operative] - It will be measured byspecular microscope
10) CV in cell size in percentage: [Time Frame: Pre-operative,and 90 day post-operative] - It will be measured by specularmicroscope
11)Cell area:[Time Frame: Pre-operative,and 90 day post-operative] - It will be measured by specular microscope
12) Cell Hexagonality: [Time Frame: Pre-operative, and 90 daypost-operative] - It will be measured by specular microscope
13) Lens Clarity: [Time Frame: 8-hours, 24 hours, 7 day, 30 day,90 day post-operative] - It will be evaluated by slit-lamp biomicroscope.
Safety Endpoint: 1) AdverseEvents[TimeFrame:intra-operativevisit,8-hours,
24 hours, 7 day, 30 day, 90 day post-operative and as andwhen occur]
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2) Iritis by Slit Lamp Examination 3) Fibrin (Grading from 0-none to 4-severe) in anterior chamber
by Slit Lamp Examination
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Parameters to beobtained duringintra-operativeprocedure
1. 1) Investigator Reported Space Maintenance: Maintenance of theanterior chamber/dome during cataract surgery. Spacemaintenance was reported during Capsulorhexis, Hydro-dissection, Phacoemulsification, and IOL insertion. This will berated by the surgeon on of the following category:
- ï€ Full Chamber Maintained
- ï€ Working Space Maintainedï€ Shallow ï€ Flat
2. 2) OVDresidingtimeinAnteriorChamber:ItwillbereportedinMinutes
3. 3) Removal time of OVD: It will be reported in Seconds
4. 4) Total Phaco time: It will be reported in Seconds
5. 5) Effective Phaco time: It will be reported in Seconds
6. 6) Average Phaco power: It will be reported in percentage
7. 7) Vacuum: It will be reported in mmHg
8. 8) Ease of removal use: It will be rated in following parametersbased on investigator’s experience.
ï€ Excellent ï€ VeryGood ï€ Good ï€ NeedsImprovement
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Study Endpoints
Primary Endpoint
To compare Bio-Hyalur Plus with the Protectalon 1.4% in terms of theincidence of IOP observations above 30 mmHg.
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ClinicalParameters
Clinical Parameters:
1 The Endothelial Cell Density Changes from pre-operative to 3months post-operative for both OVD group.
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2. 2 The grade of inflammation will be tabulated with the frequencyand proportion of eyes with each grading for each event overtime and cumulatively will be presented for both OVD groups.
3. 3 The grade of corneal clarity will be tabulated with the frequencyand proportion of eyes with each grading for each event overtime and cumulatively will be presented for both OVD groups.
4. 4 The change in Visual acuity (UCVA & BCVA) from baselinewill be presented by descriptive statistics for the 1-month and 3-month postoperative by OVD groups.
5. 5 The frequency and proportion of monocular BCVA will bereported over time by visual acuity line. Monocular BCVApercent 20/40 or better will also be compared to ISO SPE rate.
6. 6 The frequency and proportion of monocular UCVA will bereported over time by visual acuity line.
7. 7 The change in corneal thickness from baseline will be presentedby descriptive statistics for the 1-week, 1-month and 3-monthpost-operative time points by OVD groups.
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Eligibility Criteria
Inclusion Criteria:
1. 1) Unilateral/Bilateral
2. 2) Age18yearorgreater
3. 3) Cataractforwhichphacoemulsificationextractionandposterior
chamber IOL implantation was planned in at least one eye of the
patient
4. 4) Clearintraocularmediaotherthancataract
5. 5) Signedinformedconsent
6. 6) Patient who are willing to attend all the regular follow-up
examinations as per the study schedule.
Exclusion Criteria:
1. 1) Concurrent participation or participation in the last 30 days in anyother clinical trial.
2. 2) Historyofprevioussteroid-inducedIOP
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3. 3) Patientwithpigmentdispersionsyndrome
4. 4) Takingmedicationsthatmayaffectvision,IOP,oreaseofcataract
surgery (e.g., Flomax, glaucoma medications, etc.)
5. 5) Acute or chronic disease or illness that would increase risk or
confound study results (e.g., diabetes mellitus,
immunocompromised, etc.)
6. 6) Uncontrolledsystemicoroculardisease.
7. 7) Historyofoculartraumaorpriorocularsurgery
8. 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial
dystrophies)
9. 9) Knownpathologythatmayaffectvisualacuity;particularlyretinal
changes that affect vision (e.g., macular degeneration, cystoid
macular edema, diabetic retinopathy, etc.)
10. 10) Any visual disorder predicted to cause future acuity loss to a level
of 0.3 LogMAR or worse
11. 11) Pseudoexfoliation
12. 12) Ocular hypertension (>22 mm Hg) or glaucomatous changes in the
optic nerve.
13. 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. 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. 15) Vulnerable subject.
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Follow-up schedule
- ï‚· Pre-operative Visit/Screening Visit
- ï‚· 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
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Apart from this follow-up schedule, if patient turned up for anyadditional unscheduled visit to clinic then data for that particular visitwill be documented in the Case Report Form (CRF) in appropriatesection.
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Statistical Analysis
The continuous data will be summarized by treatment groups usingdescriptive statistics (number of eyes (n), mean, standard deviation(SD), median, minimum and maximum). Categorical data will besummarized by different OVDs using frequency count (n) andpercentages (%). All statistical tests will be conducted at the 5%significance level, unless indicated otherwise.
The analysis of performance will be performed on all the patients inmITT and PP population. Any missing post-baseline data will beimputed using the last observation carried forward (LOCF).
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EthicalConsideration
The clinical investigation plan, informed consent form and other studyrelated documents must be submitted to the appropriate EthicsCommittee (EC) and written approval must be obtained. Theinvestigator will not make any change in the research without ECapproval, except when necessary to eliminate immediate hazards tohuman patients. The Investigator will promptly report to the ECproposed changes and all unanticipated problems involving risks tohuman patients or others.
These amendments involving significant risk or changes requiring ECapproval and written documentation of this approval must be submittedby the investigator before implementation except in case of emergencywhere the investigator may implement the amendments and then informthe EC as soon as possible.
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Quality Standard
This study will follow Declaration of Helsinki (in accordance with theapplicable country’s acceptance), ICH standards for clinical researchincluding ICH-E6 (GCP) and ICH-E3 (Study Reporting); ISO 14155standards for Conduct of the study. The quality plan will be prepared inaccordance with ISO 14155 and ICH-GCP guidelines.
Quality assurance for the data and conduct of the study is primarily theresponsibility of the Investigator. The Investigator will ensure that thestudy complies with the norms of GCP and ISO 14155. The localregulations will be followed in data management quality assurance.Proper due diligence will be conducted before a service is outsourcedto any clinical vendor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria: 1) Unilateral/Bilateral 2) Age18yearorgreater 3) Cataractforwhichphacoemulsificationextractionandposterior chamber IOL implantation was planned in at least one eye of the patient 4) Clearintraocularmediaotherthancataract 5) Signedinformedconsent 6) Patient who are willing to attend all the regular follow-up examinations as per the study schedule.
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- Concurrent participation or participation in the last 30 days in any other clinical trial.
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- Historyofprevioussteroid-inducedIOP 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) Uncontrolledsystemicoroculardisease.
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- Historyofoculartraumaorpriorocularsurgery 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies) 9) Knownpathologythatmayaffectvisualacuity;particularlyretinal 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.
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- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare Bio-Hyalur Plus with the Protectalon 1.4% in terms of the incidence of IOP observations above 30 mmHg. intra-operativevisit,8-hours, | 24 hours, 7 day, 30 day, 90 day post-operative and as and when occur]
- Secondary Outcome Measures
Name Time Method The Endothelial Cell Density Changes from pre-operative to 3 months post-operative for both OVD group. 2 The grade of inflammation
Trial Locations
- Locations (1)
The Eye Foundation
🇮🇳Coimbatore, TAMIL NADU, India
The Eye Foundation🇮🇳Coimbatore, TAMIL NADU, IndiaShreyas RamamurthyPrincipal investigator9894231663shreyas@theeyefoundation.in