This study will assess the outcome and efficacy of a new viscoelastic device which is used for protecting the corneal endothelium during cataract surgery.

Not Applicable

Not yet recruiting

• Conditions: Age-related nuclear cataract,

• Registration Number: CTRI/2023/11/060182
• Lead Sponsor: Biotech Ophthalmics Pvt Ltd

Brief Summary

3 SYNOPSISTitle of StudyA prospective, open-label, single arm clinical study to evaluate thesafety & performance of Eyevisc 2.4% OVD in patient undergoingcataract surgery.Protocol No, Version, Date BVCPL-HPMC-2023-01, 1.0, 24-July-2023Study DeviceEYEVISCâ„¢ 2.4% (Hydroxypropyl Methylcellulose 2.4 %) (BiotechVision Care Pvt. Ltd.)Study DesignThis study is a prospective, open-label, single arm clinical study toevaluate the safety & performance of Eyevisc 2.4% OVD in patientundergoing cataract surgery.Number of patients 131 eyesNumber of Centers 1 CenterDuration of clinicalStudy 9 Month (6 Month for enrolment and 3 month for follow-up)ObjectivesPrimary Objective: ï‚· To evaluate the performance of EYEVISC 2.4% in patientundergoing cataract surgery.Secondary Objectives: ï‚· To evaluate the safety of EYEVISC 2.4% in patient undergoingcataract surgery.Study EndpointsPrimary Endpoint1. Percentage of participants with postoperative intraocular pressureof at least 30 mm Hg [Time Frame: 3 Months]2. Percent change in Mean Epithelial Cell Density (ECD) (Safetyend point) [Time Frame: 3 Months]Secondary Endpoint1. Grade of Cataract2. Investigator Reported Space Maintenance3. Total Phaco time4. Effective Phaco time5. Average Phaco power  6. Vacuum7. Change in Corneal thickness8. Intraocular Inflammation with Grade of Inflammation9. Corneal Clarity10. CV in cell size11. Cell area12. Number of cell analyzed13. Cell Hexagonality14. Adverse Event/complicationClinical Parameter1) Intraocular Pressure [Time frame: Pre-operative, 8 hours, 24hours, 7 days, 30 days and 90 days post-operative] Intraocularpressure will be measured by Goldmann ApplanationTonometry in mmHg.2) Corneal Endothelium Cell Density [Time Frame: Pre- operative, Post-operative 7 days, 30 days and 90days] Endothelial cell count (cell/mm2) will be performed bycounting of cells on photographic image of endothelium takenby Specular Microscope (cell/mm²). 3) Intraocular Inflammation with Grade ofInflammation [Time Frame: Pre-operative, post-operative 24hours, 7 days, 30 days and 90 days] Measurement performedby slit-lamp bio microscopy. Grading of Inflammation will bedone based on Aqueous cells and flares as per StandardizationUveitis Nomenclature (SUN):Grade Cells\* Flare0 None None0.5 + 1-5 cells infield --- 1 + 6-15 cells Faint2 + 16-25 cells Moderate (Iris and lens details areclear)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 hypopyonshould 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 cornealthickness will be measured in micrometre (µm). Measurementperformed by SIRIUS topographer.5) Visual Acuity [Time Frame: Pre-operative, Post-operative 7days, 30 days and 90 days] Visual Acuity (VA) is measured inLogMAR. LogMAR is the "logarithm of the minimum angleof resolution". A lower LogMAR value indicates better visualacuity. 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-operative8 hours, 24 hours, 7 days, 30 days and 90 days] It will beevaluated by slit-lamp bio microscope. Grading of cornealclarity on the basis of corneal haze as following;Grade Detail0 No corneal haze1 Iris details visible2 Pupillary margin visible, iris details not visible3 Pupillary margin not visible4 Cornea totally opaque7) Cell Area [Time Frame: Pre-operative, Post-operative 90days] It will be measured by Specular Microscope8) Cell Hexagonality [Time Frame: Pre-operative, Post- operative 90 days] It will be measured by SpecularMicroscope9) Slit Lamp Examination [Time Frame: Pre-operative, Post- operative 8 hours, 24 hours, 7 days, 30 days and 90 days] ï‚· Cells ï‚· Corneal Clarityï‚· Fibrin (grading from 0-none to 4-severe) in anteriorchamber by slit lamp examinationï‚· Flare  ï‚· Iritis ï‚· Lens ClaritySafety Endpoint:1) Adverse Events [Time Frame: Intra-operative visit, Post- operative 8-hours, 24 hours, 7 days, 30 days, 90 days and asand when occur]Parameters to beobtained duringintra-operativeprocedure1) 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:  Full Chamber Maintained  Working Space Maintained  Shallow Flat2) OVD residing time in Anterior Chamber: It will be reported inMinutes3) Removal time of OVD: It will be reported in Seconds4) Total Phaco time: It will be reported in Seconds5) Effective Phaco time: It will be reported in Seconds6) Average Phaco power: It will be reported in percentage7) Vacuum: It will be reported in mmHg8) Ease of removal: It will be rated in following parameters basedon investigator’s experience.  Excellent  Very Good  Good- Needs ImprovementEligibility CriteriaInclusion Criteria:1) Unilateral/Bilateral2) Age ≥ 45 year or greater. 3) Cataract for which phacoemulsification extraction and posteriorchamber IOL implantation was planned in at least one eye of thepatient. 4) Clear intraocular media other than cataract.5) Signed informed consent. 6) Patient who are willing to attend all the regular follow-upexaminations as per the study schedule.7) Patients with Grade I to III cataract and used OVDs8) 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 wasgreater than 7.0 mmExclusion Criteria:1) Concurrent participation or participation in the last 30 days in anyother clinical trial.2) History of previous steroid - induced IOP3) Patient with pigment dispersion syndrome4) Taking medications that may affect vision, IOP, or ease of cataractsurgery (e.g., Flomax, glaucoma medications, etc.)5) Acute or chronic disease or illness that would increase risk orconfound 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 endothelialdystrophies).9) Known pathology that may affect visual acuity; particularly retinalchanges that affect vision (e.g., macular degeneration, cystoidmacular edema, diabetic retinopathy, etc.).10) Any visual disorder predicted to cause future acuity loss to a levelof 0.3 LogMAR or worse.  Pseudoexfoliation12) Ocular hypertension (>22 mm Hg) or glaucomatous changes in theoptic nerve.13) Endothelial cell counts lower than 1500 cells/mm2 preoperatively(based on the lowest value of three cell counts performed bytechnician at investigative site).14) Patient is pregnant, planned to become pregnant, lactating or hadanother condition associated with the fluctuation of hormones thatcould lead to refractive changes.15) Vulnerable subject.16) Black, Brunescent, traumatic or subluxated cataract.17) Patient who had Glaucoma, Pseudo exfoliation Syndrome with Irisatrophy, uveitis, Proliferative diabetic retinopathy at the time ofsurgery (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 Hg20) Surgery of the contralateral eye performed or planned within aperiod of 7 days before or after the surgery of the studied eyeRational andjustificationJustification forstudy designIt is a prospective, open-label, single-arm, post market clinical studywhere in only one HPMC OVD will be used during the surgicalprocedure, the clinical data obtained will be statistically analysed as perdefined ISO standard and will be reported. The rationale of conductingthis study is to prospectively evaluate the performance, safety andefficacy of Eyevisc in patients undergoing routine cataract surgery.A Rationale for the Choice of the control OVDNot applicable as it is single arm study.Follow-up scheduleï‚· Pre-operative Visit/Screening Visit ï‚· Surgery Visit/Intra-operative Visit ï‚· Post-operative 8 hours ± 2 hours ï‚· Post-operative 24 hours ± 4 hours ï‚· Post-operative 7 Days ± 2 days  ï‚· Post-operative 30 days ± 7 days ï‚· Post-operative 90 days ± 14 daysApart 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.Statistical AnalysisThe continuous data will be summarized using descriptive statistics(number of subjects (n), mean, standard deviation (SD), median,minimum and maximum). Categorical data will be summarizedfrequency count (n) and percentages (%). All statistical tests will beconducted at the 5% significance level, unless indicated otherwise.Primary Endpoint:The EYEVISC 2.4% in terms of the incidence of IOP observationsabove 30 mmHg will be summarized using descriptive statistics at eachvisit.Other parameters analysis:Intraocular Pressure, Corneal Endothelium Cell, IntraocularInflammation with Grade of Inflammation, Corneal Thickness, Visualacuity, Corneal clarity, Cell Area, Cell Hexagonality and Slit lampexamination will be summarized using descriptive statistics. A detailed description of the analysis will be provided in statisticalanalysis plan.EthicalConsiderationThe clinical Study plan, informed consent form and other study relateddocuments must be submitted to the appropriate Ethics Committee (EC)and written approval must be obtained. The investigator will not makeany change in the research without EC approval, except when necessaryto eliminate immediate hazards to human patients. The Investigator willpromptly report to the EC proposed changes and all unanticipatedproblems involving risks to human 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 131

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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of participants with postoperative intraocular pressure	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]
of at least 30 mm Hg [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]
2. Percent change in Mean Epithelial Cell Density (ECD) (Safety	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]
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 Measures

Name	Time	Method
1. Change in Corneal thickness	2. Intraocular Inflammation with Grade of Inflammation

Trial Locations

Locations (1)

The Eye Foundation; 🇮🇳 Coimbatore, TAMIL NADU, India

The Eye Foundation

🇮🇳Coimbatore, TAMIL NADU, India

Shreyas Ramamurthy

Principal investigator

9894231663

shreyas@theeyefoundation.in