Clinical study, to Investigate the Safety and Device Performance of Pars Plana Vitrectomy Surgery Using a Hypersonic Vitrector Handpiece.

Not Applicable

Completed

Conditions: For vitrectomy based on a diagnosis of one of the following conditions: vitreoretinal traction, asteroid hyalosis, macular pucker/epiretinal membrane, macular hole, or vitreous hemorrhage

Registration Number: CTRI/2017/07/008975

Lead Sponsor: Bausch Lomb Incorporated

Brief Summary: This is a single-arm, non-comparative, uncontrolled, open-label, monocular study to assess the safety and device performance of a hypersonic vitrector handpiece.

Eligible subjects who are enrolled in the study will undergo a screening visit up to 14 days prior to surgery, a vitrectomy procedure in the study eye, and be clinically followed for 3 months after surgery.

Enrolled subjects who meet eligibility criteria will be seen according to the following schedule:

Pre-operative Visit            Day -14 to -1

Operative Visit                  Day 0

Post-operative Visit 1       1 Day

Post-operative Visit 2       7 Days +/- 2 days

Post-operative Visit 3       30 Days +/- 7 days (interim observations)

Post-operative Visit 4       90 Days +/- 14 days (final observations)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

This study will include subjects who meet all of the following: 1.Subjects must be 40 years of age or older on the date the Informed Consent Form (ICF) is signed.
2.Subjects must provide written informed consent on the IRB/EC-approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy protection regulations.
3.Subjects must be willing and able to comply with all treatment and follow-up study procedures.
4.Subjects undergoing optical coherence tomography (OCT) and fundus imaging must have adequate pupillary dilatation and clear media to perform imaging studies including fundus fluorescein angiography.
5.Subject must have a clinical indication for vitrectomy based on a diagnosis of one of the following conditions: vitreoretinal traction, asteroid hyalosis, macular pucker/epiretinal membrane, macular hole, or vitreous hemorrhage 6.Subject must have uncorrected visual acuity worse than 20/40 (Snellen) at Visit 1.

Exclusion Criteria

The patients will be excluded from the study based on the following exclusion criteria: 1.Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.
2.Subjects with retinal disorders in the study eye that may confound interpretation of or prevent obtaining fundus fluorescein angiography (FA) or OCT images, including retinal vascular occlusion, choroidal neovascularization, macular atrophy or scarring, ocular histoplasmosis, or pathologic myopia.
3.Subjects who have had prior vitrectomy surgery, cryopexy, or retinal buckle procedure.
4.Subjects with prior history of retinal tear, vitreoretinal tractional detachment, or ocular tumors in either eye.
5.Subjects with visual acuity of No Light Perception at Visit 1.
6.Female subjects of child-bearing potential who have a positive urine test for pregnancy at Visit 1.
7.Subjects who have experienced any significant trauma in the operative eye within the past month.
8.Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
9.Subjects with history of complicated cataract surgery involving vitreous loss or a history of vitreoretinal surgery in the study eye.
10.Subjects with uncontrolled glaucoma or ocular hypertension (IOP > 24 mmHg) in the operative eye.
11.Subjects with dislocated lens or retained lens fragments.
12.Subjects with a known bleeding disorder or using drugs known to increase the likelihood of bleeding.
13.Subjects with uveitis refractory to treatment.
14.Subjects with significant anterior segment abnormality that would interfere with visualization of the vitreous or retina.
15.Subjects with a known allergy to sodium fluorescein dye.
16.Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigatorâ€™s medical judgment, poses a concern for the subjectsâ€™ safety.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the performance quality of a study device for pars plana vitrectomy surgery.	NA
Determine the range of time and device settings required to complete a vitrectomy	NA
Assess surgeon assessed device adequacy for removal of core / peripheral vitreous, vitreous hemorrhage and for induction of PVD in subjects requiring the use of a vitrector	NA
Verify no significantly different post surgical pathologic retinal changes due to study device	NA

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1): Agarwalâ€™s Eye Hospital
🇮🇳
Chennai, TAMIL NADU, India
Agarwalâ€™s Eye Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr Amar Agarwal
Principal investigator
04428112811
aehl19c@gmail.com