Ultrasound Biomicroscopy Study Of Accommodative State In Smartphone Abusers

August 28, 2021 updated by: Randa Farouk Kashif
Detection if there is association between spasm of accommodation and smart phone abuse by ultrasound biomicroscopy on anterior segment of the eye

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Group (A): 40 smart phone abuser subjects (According to the smartphone questionnaire).

Group (B): 40 smart phone non user subjects.

Description

Inclusion Criteria:

  1. Age 18 - 35 year.
  2. Smart phone excessive use.
  3. Emmetrope and myope patients.

Exclusion Criteria:

  1. Hypermetrope patients.
  2. Any form of tropia.
  3. Anterior segment diseases either congenital or acquired.
  4. Previous intraocular surgeries.
  5. Presbyopic subjects.
  6. Drugs induced spasm of accommodation: psychiatric drugs, pilocarpine, physostigmine, echothiophate, prostigmine, isoflurophate, muscarine, digitalis overdose and with sulphonamides
  7. CNS diseases : Neurosyphilis, Raeder paratrigeminal neuralgia syndrome, cyclic oculomotor palsy, pineal tumor, Chiari malformation, pituitary tumor, metabolic encephalopathy,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
smartphone abusers

Auto refractometer without cycloplegia Uncorrected visual acuity (logMAR conversion). Anterior segment slit lamp examination UBM examination settings :Supine decubitus position.5150 Vumax (Sonomed, USA) under standard illumination Parameters that will be measured: corneal thickness, anterior chamber depth, angle to angle distance, cornea-posterior capsular lens distance, lens thickness, pupillary diameter, angle of anterior champer and trabecular-ciliary process distance.

Cycloplegic refraction UBM examination will be repeated after cycloplegia with the same settings. The patients found to have spasm of accommodation will be subjected to ways to relief the spasm of accommodation and repetition of UBM if possible
Diagnostic test: Ultrasound Biomicroscopy of anterior segment of the eye
5150 Vumax (Sonomed, USA) under standard illumination
Other Names:
  • UBM
smartphone non users

Auto refractometer without cycloplegia Uncorrected visual acuity (logMAR conversion). Anterior segment slit lamp examination UBM examination settings :Supine decubitus position.5150 Vumax (Sonomed, USA) under standard illumination Parameters that will be measured: corneal thickness, anterior chamber depth, angle to angle distance, cornea-posterior capsular lens distance, lens thickness, pupillary diameter, angle of anterior champer and trabecular-ciliary process distance.

Cycloplegic refraction UBM examination will be repeated after cycloplegia with the same settings. The patients found to have spasm of accommodation will be subjected to ways to relief the spasm of accommodation and repetition of UBM if possible
Diagnostic test: Ultrasound Biomicroscopy of anterior segment of the eye
5150 Vumax (Sonomed, USA) under standard illumination
Other Names:
  • UBM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in objective refraction measured before and after cycloplegia
Time Frame: 40-60 minutes after instillation of cycloplegic drop
diopter
40-60 minutes after instillation of cycloplegic drop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Randa Farouk Kashif

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MD 43/2017
  • Research Ethics Committee (Other Identifier: The Research Ethics Committee of the College of Dentistry, University of Baghdad. Project No. 1026125)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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