Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-04-27

Brief Summary

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Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness.

One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be a single centre, single-arm, prospective pilot study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single arm

This will be a single centre, single-arm, prospective pilot study.

Group Type OTHER

Single arm

Intervention Type OTHER

Far Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire

Interventions

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Single arm

Far Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient \> 18 years old, both genders
2. Diagnosed with glaucoma, with controlled IOP (\<18mmHg)
3. Currently receiving a topical glaucoma treatment
4. Receiving a multitherapy a fixed combination of dorzolamide-timolol, preservative-free.
5. Patient willing to participate in the study.
6. Patient familiar with a smartphone and its applications

Exclusion Criteria

1. Patient with any eye condition in addition to glaucoma requiring expected additional treatment
2. Patient with an ongoing or known history of ocular allergy and/or uveitis and/or viral infection and or ocular infection.
3. Patient who underwent intraocular surgery within the past 3 months or scheduled to undergo intraocular surgery within the next 3 months
4. Patient with best-correct visual acuity \<20/70 in the better seeing eye
5. Patient whose drop administration is performed by someone else
6. Alcohol addiction and/or heavy smoker, according to the investigator's judgement.
7. Patient inability to understand the study procedures or to give informed consent.
8. Non-compliant patient (e.g., not willing to attend a visit; way of life interfering with compliance).
9. Participation in this study at the same time as in another clinical study.
10. Patient being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study sites or of the sponsor's company.
11. Patient not covered by the government health care scheme of the country in which he/she is living (if applicable).
12. Women of childbearing potential, pregnant or breastfeeding: Childbearing potential is defined as a woman who is not using a reliable method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, patch) or is not surgically sterilized.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No