Spasm of AccommodationNCT03389009
Ultrasound Biomicroscopy Study Of Accommodative State In Smartphone Abusers
An observational study of Spasm of Accommodation, run by Randa Farouk Kashif.
Trial summary
Detection if there is association between spasm of accommodation and smart phone abuse by ultrasound biomicroscopy on anterior segment of the eye Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Spasm of Accommodation
- What is being tested?
- Ultrasound Biomicroscopy of anterior segment of the eye
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group (A): 40 smart phone abuser subjects (According to the smartphone questionnaire). Group (B): 40 smart phone non user subjects.
Who may be able to join
- Age 18 - 35 year.
- Smart phone excessive use.
- Emmetrope and myope patients.
Who cannot join
- Hypermetrope patients.
- Any form of tropia.
- Anterior segment diseases either congenital or acquired.
- Previous intraocular surgeries.
- Presbyopic subjects.
- Drugs induced spasm of accommodation: psychiatric drugs, pilocarpine, physostigmine, echothiophate, prostigmine, isoflurophate, muscarine, digitalis overdose and with sulphonamides
- CNS diseases : Neurosyphilis, Raeder paratrigeminal neuralgia syndrome, cyclic oculomotor palsy, pineal tumor, Chiari malformation, pituitary tumor, metabolic encephalopathy,
About this study
Detection if there is association between spasm of accommodation and smart phone abuse by ultrasound biomicroscopy on anterior segment of the eye
- Conditions
- Spasm of Accommodation
- Being tested
- Ultrasound Biomicroscopy of anterior segment of the eye
- Medical subject headings
- Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Biomicroscopy of anterior segment of the eyeDiagnostic test
Also called UBM
5150 Vumax (Sonomed, USA) under standard illumination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Ultrasound Biomicroscopy of anterior segment of the eye | |
| 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 Receives: Diagnostic Test: Ultrasound Biomicroscopy of anterior segment of the eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in objective refraction measured before and after cycloplegia
diopter
Measured: 40-60 minutes after instillation of cycloplegic drop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Oct 2016
- Primary completion15 Dec 2016
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasm of AccommodationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randa Farouk Kashif
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Randa Farouk Kashif, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389009
- Sponsor's protocol ID
- FMASU MD 43/2017
- Other IDs
- research ethics committee
- Status last verified
- Aug 2021
- First submitted
- 21 Oct 2017
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Biomicroscopy Study Of Accommodative State In Smartphone Abusers
- ClinicalTrials.gov ID
- NCT03389009
- Acronym / sponsor ID
- FMASU MD 43/2017
- Conditions
- Spasm of Accommodation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Randa Farouk KashifUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detection if there is association between spasm of accommodation and smart phone abuse by ultrasound biomicroscopy on anterior segment of the eye
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smartphone abusers | – | Diagnostic Test: Ultrasound Biomicroscopy of anterior segment of the eyeAuto 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 |
| smartphone non users | – | Diagnostic Test: Ultrasound Biomicroscopy of anterior segment of the eyeAuto 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group (A): 40 smart phone abuser subjects (According to the smartphone questionnaire). Group (B): 40 smart phone non user subjects.
Key inclusion criteria (3 listed)
- Age 18 - 35 year.
- Smart phone excessive use.
- Emmetrope and myope patients.
Key exclusion criteria (7 listed)
- Hypermetrope patients.
- Any form of tropia.
- Anterior segment diseases either congenital or acquired.
- Previous intraocular surgeries.
- Presbyopic subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Biomicroscopy of anterior segment of the eyeAlso: UBM5150 Vumax (Sonomed, USA) under standard illumination | Diagnostic test | smartphone abusers, smartphone non users |
Primary outcome
Difference in objective refraction measured before and after cycloplegia
Time frame: 40-60 minutes after instillation of cycloplegic drop
diopter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasm of Accommodation, run by Randa Farouk Kashif.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in objective refraction measured before and after cycloplegia (time frame: 40-60 minutes after instillation of cycloplegic drop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.