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The G4 Multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. The lens covers the cornea and part of the sclera. The lenses can be used for daily wear for up to 1 year.
Study Design:
A clinical performance study without a control group to compare the G4Multi contact lens to other approved soft contact lenses for presbyopia
Study Objectives:
Study population:
Healthy men and women above the age of 18 diagnosed with presbyopia who have used contact lenses in the past
Recruitment :
A total of 30 subjects completing at least 1 month of participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | G4 Multifocal soft contact lens with a 54% water content for presbyopia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G4 Multifocal soft contact lens with a 54% water content for presbyopia | Device | The participants must agree to wear lenses from a trial set with the fit assessed according to the "Fitting Guide". Prescription lenses will then be ordered from the manufacturer. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess 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 measured with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms. Results will be recorded in a Log Mar scale. | 11-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess subjective degree of comfort while wearing the lenses | Participants will be asked to fill in a "Subjective Use Questionnaire" (appendix 2) . | 11-12 months |
| SLIT LAMP EXAM | The slit lamp exam will include the entire cornea, sclera and conjunctiva exclusion symptoms: See ISO 11980 Annex B (informative) Procedures for the evaluation of safety, physiological performance and effects on ocular tissues. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLC | Raanana | Israel | ||||
| Bar Ilan |
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| 11-12 months |
| Ramat Gan |
| Israel |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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