Status:
COMPLETED
A Comparison of Two Devices for Taking Measurements of the Eye to Assist in Lens Selection for Cataract Surgery
Lead Sponsor:
Ziemer Ophthalmic Systems AG
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the Ziemer Ophthalmic Systems AG GALILEI G6 Lens Professional to the Oculus Pentacam® AXL for taking images and measurements of the anterior segment of the eye,...
Detailed Description
A corneal topographer/biometer named GALILEI G6 Lens Professional was developed by Ziemer Ophthalmic Systems AG for the measurement of anterior segment geometry and axial intraocular distances. The me...
Eligibility Criteria
Inclusion
- Satisfies one of the subject group categories and the enrollment quota for that category has not been reached:
- Normal eyes (phakic eyes without cataracts or corneal disease, refraction ≥ -5.5 D or ≤ +5.0 D)
- Eyes having undergone previous refractive surgery (LASIK or PRK)
- Eyes with cataracts (LOCS III grading with grades 2-6 in any or all of the posterior subcapsular (P2-P5), nuclear (N2-N5) and cortical (C2-C5), assessed by slit lamp examination; no other known ocular pathology)
- Eyes with severe myopia (≤ -6 D according to the American Academy of Ophthalmology)
- Eyes with severe hyperopia (≥ +5.25 D according to the American Academy of Ophthalmology)
- Eyes with previous cross-linking and eyes with advanced keratoconus
- Manifest refraction sSpherical eEquivalent Refraction (MRSER) between -10dpt and +10dpt as measured by cycloplegic autorefraction assessed less than 12 months prior to enrollment
- Best corrected visual acuity (BCVA) of LogMAR 0.2 or better
Exclusion
- Strabismus, nystagmus, amblyopia, anisometropia (difference in MRSER\>3D)
- Angle closure glaucoma
- Seizure disorder, brain damage, Down Syndrome, Trisomy 13 or 18, Cerebral Palsy or other serious ophthalmic or central nervous system disorders
- Severe dry eye
- Severe corneal scarring
- Inability to hold gaze
- Inability to see fixation target
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03396003
Start Date
January 5 2018
End Date
August 1 2018
Last Update
September 26 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ziemer Ophthalmic Systems AG
Port, Switzerland