An interventional study of Surgical procedure in Cataract, sponsored by Hanita Lenses. Status unknown at 1 site in Israel. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-09.
Sponsored by Hanita Lenses · Not applicable, Interventional, and Treatment
CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery.
Study Design:
This study is a prospective, single-group, single-center, open-label study. Each study subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye.
Study population:
Men and women designated for cataract surgery that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 20 subjects will be enrolled.
Investigational sites:
Single-center study.
Duration of Subject participation:
The primary endpoint will be achieved when the study subject has completed a 1-month follow-up after the implantation of the CleaRing device.
Study Group:
Each subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye.
Visits \& Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including the subject's medical complaints, medical history, medication use, and ophthalmic examinations.
Surgical procedure: Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.
Follow-up: All subjects will have regular follow-up visits at the following post-operative periods: 1 day, 7 days, and 1 month. All postoperative visits will include a complete ophthalmic examination, a record of medications used, and documentation of adverse events.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Hanita Lenses is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The subject is between 50 and 80 years of age The subject is designated for cataract surgery
Eye designated for the study fulfills the following criteria:
Exclusion Criteria:
Hanita CleaRing device (CE approved; AMAR Certificate)
Device: Surgical procedure
Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.
VISUAL ACUITY
Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be done with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms. Visual acuity will be measured with either Snellen or ETDRS format charts for distance. Results will be recorded in a LogMar scale.
Time frame: 1 month
SLIT LAMP EXAM
The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion, degree of posterior capsular opacification and correct position of the IOL and the CleaRing device. For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading: Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = \> 30 cells seen Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance.
Time frame: 1 month
MEASUREMENT OF INTRAOCULAR PRESSURE
Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.
Time frame: 1 month
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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