<?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>IRCT20260208068791N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-17</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of correcting refractive errors with glasses on sleep quality</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of correcting refractive errors with glasses on sleep quality in employees aged 30 to 40 years visiting an eye clin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Refractive errors. Condition 2: sleep quality.</hc_freetext>
      <i_freetext>The intervention consists of optical correction of participants’ refractive errors using appropriate spectacle lenses. Following a complete optometric examination, a standard and up-to-date prescription is provided for each participant. Participants are instructed to wear the prescribed spectacles for at least eight hours per day over a four-week period. Visual parameters, sleep quality, and higher-order optical aberrations are assessed before and after the intervention..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashkan Amirabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Madar Square, Shahid Shah Nazari Street, Madakaran Street, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>opt.ashkan@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashkan Amirabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Madar Square, Shahid Shah Nazari Street, Madakaran Street, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>opt.ashkan@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 30 and 40 years
Presence of corrected refractive error with asthenopia in the mild to moderate range (myopia up to -6 diopters, hyperopia up to +4 diopters, astigmatism up to 2 diopters), so that the patient needs optical correction, but not complete correction.
Not wearing glasses in the past 6 months or current prescription is inappropriate
Written consent to participate in the study
Having eyes (asthenopia)
Not having presbyopic qualities and having perfect nearsightedness</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any active anterior and posterior segment disease of the eye
History of eye surgery (including refractive surgery, cataract surgery, corneal transplantation, ring, cross-linking, etc.)
History of eye trauma
Accommodation and vergence disorders, strabismus, amblyopia or history of related treatments in the past
Systemic diseases affecting eye refractive errors (such as systemic autoimmune diseases, thyroid diseases, diabetes, etc.)
Psychiatric disorders or use of psychotropic drugs
Use of drugs that affect sleep or vision such as benzodiazepines, hypnotics, ophthalmic drugs with CNS effects in order to reduce confounding factors in examining the effect of uncorrected refractive errors on sleep quality.
Wearing any type of contact lenses in the last month
Regular coffee and caffeinated beverages
People with stressful, shift or hourly jobs
Working in bright and noisy environments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H52</hc_code>
      <hc_code>G47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of refraction and accommodation</hc_keyword>
      <hc_keyword>Sleep disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention consists of optical correction of participants’ refractive errors using appropriate spectacle lenses. Following a complete optometric examination, a standard and up-to-date prescription is provided for each participant. Participants are instructed to wear the prescribed spectacles for at least eight hours per day over a four-week period. Visual parameters, sleep quality, and higher-order optical aberrations are assessed before and after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: The primary outcome measures include baseline (before optical correction) and 4 weeks after optical correction and continued use of glasses. At these two time points, sleep quality is measured and compared. Method of measurement: Sleep quality is measured using the Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>High-order optical aberration. Timepoint: The primary outcome measures include baseline (before optical correction) and 4 weeks after optical correction and continued use of glasses. At these two time points, higher-order optical aberrations are measured and compared. Method of measurement: Higher-order optical aberrations are measured using a pentacam device based on Zernike coefficients and the root mean square value of the aberrations is recorded.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-14</approval_date>
        <contact_name>Ethics Committee of the Faculty of Rehabilitation Sciences, Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Mirdamad, Madar Square, Shah Nazari Street, Madakaran Street, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
