<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20251018067676N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-01</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of vision therapy on presbyopia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vision therapy on reduction or delaying presbyopia symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/86903</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The examiner (researcher) does not know which group the patient is placed in. Patients are informed about both methods after an initial assessment. Assignment to each group is determined by the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Presbyopia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Accommodative training.The Hart chart exercises, far to near accommodative rock (5 minutes), Push-ups and Push-downs (5 minutes), Flipper lense, and Loose rock lenses (5 minutes) will be performed 5 days a week for 15 minutes a day for two months to improve amplitude and faccility of accommodation. Intervention 2: Control group: Glasses for near vision.Glasses are used for precise activities at close range, and the duration of use depends on the duration of the individual's visual work.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data can be shared after anonymizing participants and maintaining privacy.

When:
Data access begins 6 months after results are published.

To whom:
For researchers

Conditions:
Data can be requested with a valid academic email.Use of data or data analysis without coordination is not permitted.

Where to obtain:
Data can be requested with a valid academic email.
Azam Abdollahi
azaabd98@gmail.com
abdollahi@sbmu.ac.ir

How to obtain:
پس از ارسال درخواست رسمی از طریق ایمیل دانشگاه، ظرف یک ماه پاسخ دریافت خواهد شد.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Optometry, Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>azaabd98@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Optometry, Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>azaabd98@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 40-45 years.
Good general condition.
No chronic diseases affecting accommodation.
No use of drugs affecting accommodation and near vision on a continuous basis.
No chronic eye diseases.
Minimum uncorrected near vision of 20/40.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to perform the tests
Strabismus
Moderate and severe Amblyopia
Significant ocular disease
Surgery or drug treatments for Presbyopia
Individuals with any systemic disease associated with Presbyopia or use of drugs (continuous or long-term)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H52.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presbyopia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Accommodative training.The Hart chart exercises, far to near accommodative rock (5 minutes), Push-ups and Push-downs (5 minutes), Flipper lense, and Loose rock lenses (5 minutes) will be performed 5 days a week for 15 minutes a day for two months to improve amplitude and faccility of accommodation.</i_keyword>
      <i_keyword>Control group: Glasses for near vision.Glasses are used for precise activities at close range, and the duration of use depends on the duration of the individual's visual work.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amplitud of accommodation. Timepoint: Before training and glasses, first month after training, second month after training and glasses. Method of measurement: Push-up and minus lens methods.</prim_outcome>
      <prim_outcome>Positive and Negative relative accommodation. Timepoint: Before training and glasses, first month after training, second month after training and glasses. Method of measurement: Positive and negative lenses.</prim_outcome>
      <prim_outcome>Accommodative facility. Timepoint: Before training and glasses, first month after training, second month after training and glasses. Method of measurement: Flipper  lens.</prim_outcome>
      <prim_outcome>Symptoms. Timepoint: Before training and glasses, first month after training, second month after training and glasses. Method of measurement: Asthenopia Questionnaire (ASQ-17).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Far and Near visual acuity. Timepoint: Before starting training and glasses, one month after training, two months after training and glasses. Method of measurement: Distance and Near vision chart.</sec_outcome>
      <sec_outcome>Refractive Errors. Timepoint: Before starting training and glasses, one month after training, two months after training and glasses. Method of measurement: Autorefractometer, Retinoscope and Subjective refraction.</sec_outcome>
      <sec_outcome>Near addition power. Timepoint: Before starting training and glasses, one month after training, two months after training and glasses. Method of measurement: Subjective refraction.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-12</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Fifth Floor, Building No. 2, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
