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Clinical trial with medical devices, post-authorization, parallel, single-blind, randomized, comparative, prospective to study how afects the quality of life the use of ocular eye drops on patients with dry eye symptomatology and age-related loss of visual acuity.
Secondary purposes: efects on the dry eye symptomatology, efect on visual acuity and treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vis Glyc Neo | Experimental | Vis glyc eye drops is administered. Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate |
|
| physiological saline solution | Active Comparator | Physiological saline solution ALVITA is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vis Glyc Neo | Device | 1 drop in each eye, three times a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of visual life: NEI VFQ-25 questionnaire | In patients with dry eye symptomatology and age-related loss of visual acuity. Assessed using NEI VFQ-25 questionnaire. It is a questionnaire with 25 questions. Its format is divided into 4 subscales: visual function, difficulty with activities, driving a car and responding to vision problems. It consists of a base of 25 questions (each with five or six levels of response and scoring ranges) addressed to vision, representing 11 domains, elements or items related to health; 1) general vision, 2) eye pain, 3) near activities, 4) distance activities, 5) social functioning, 6) mental health, 7) role difficulties or limitations, 8) dependence, 9) driving, 10) color vision and 11) peripheral vision. Each domain receives an evaluation from 0 to 100; the high evaluation represents changes in visual functioning, where 0 is the lowest and 100 is the best possible. | Change from baseline quality of life at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of visual life: NEI VFQ-25 questionnaire | In patients with dry eye symptomatology and age-related loss of visual acuity. Assessed using NEI VFQ-25 questionnaire. It is a questionnaire with 25 questions. Its format is divided into 4 subscales: visual function, difficulty with activities, driving a car and responding to vision problems. It consists of a base of 25 questions (each with five or six levels of response and scoring ranges) addressed to vision, representing 11 domains, elements or items related to health; 1) general vision, 2) eye pain, 3) near activities, 4) distance activities, 5) social functioning, 6) mental health, 7) role difficulties or limitations, 8) dependence, 9) driving, 10) color vision and 11) peripheral vision. Each domain receives an evaluation from 0 to 100; the high evaluation represents changes in visual functioning, where 0 is the lowest and 100 is the best possible. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz Sarmiento Torres, MD, MSc | Hospital Universitario 12 Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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Single-blinded: The physician performing the recruiting will be different and cannot be related to the investigator evaluating the follow-up.
| Physiological saline solution |
| Device |
1 drop in each eye, three times a day. |
|
| 0, 30, 90, 180 days |
| Visual Acuity Evaluation I | To assess the age-related visual acuity in patients. - The CSV-1000E contrast sensitivity test. This test provides for four (4) rows of sine-wave gratings. These gratings test the spatial frequencies of 3, 6, 12 and 18 cycles/degree (CPD). The levels of contrast are 1 to 8. The higher the contrast or modulation, the greater the difference in luminance and the better the object will be distinguished from the background. | 0, 90, 180 days |
| Visual Acuity Evaluation II | To assess the age-related visual acuity in patients. - LOCS III classification of cataract grade using images obtained by ophthalmoscopy with slit lamp, which allows the study of the anterior segment of the patient's eye. It consists of six slit lamp images to evaluate core color (NC) and opalescence (NO); five backlit images to evaluate cortical cataract (C); and five backlit images to evaluate posterior subcapsular cataract (P). The severity of the cataract is classified on a decimal scale, and the patterns have regularly separated intervals on a decimal scale. | 0, 90, 180 days |
| Visual Acuity Evaluation III | To assess the age-related visual acuity in patients. - Visual acuity test with the best correction in each eye using Snellen E-screens, measured in decimal system and MAR logarithm. Level of vision with respect to the row in Snellen's graph, which the rows consist of 1 to 11. The lower the row (greater numbers) the patient can distinguish, the greater the visual acuity he will have. | 0, 90, 180 days |
| Dry eye symptomatology Evaluation I | Schirmer I test (without anesthesia): to determine the dryness of the eye. It consists of placing a thin strip of paper at the bottom of the conjunctival sac and before this foreign body see the patient's tear production capacity (measuring the wet area in mm). The less mm the less tear production capacity. | 0, 90, 180 days |
| Dry eye symptomatology Evaluation II | - Fluorescein staining test: to assess dryness of the eye. Fluorescein is instilled in both conjunctival sacs. Absence of staining indicates integrity of the corneal epithelium. There are degrees of fluorescein staining from 0 to 5. The highest the worst results. | 0, 90, 180 days |
| Dry eye symptomatology Evaluation III | The OSDI Test (ocular surface disease index) is a simple test created to establish the severity and classification of dry eye according to its symptoms. It is based on 12 different questions about situations related to patient symptomatology. A score of 100 corresponds to a total disability (answer "At all times" to all questions answered), while a score of 0 corresponds to no disability. | 0 and 180 days |
| Treatment adherence | Ask patients about the daily administration of the treatment according to the protocol. | 30, 90 and 180 days |
| Adverse events | Number of participants with Adverse events and types of adverse events. | 30, 90 and 180 days |