<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993081</url>
  </required_header>
  <id_info>
    <org_study_id>ARVO R1 2017</org_study_id>
    <nct_id>NCT02993081</nct_id>
  </id_info>
  <brief_title>Capsulotomy YAG Laser</brief_title>
  <acronym>RCYAG</acronym>
  <official_title>REFRACTIVE CHANGES AFTER CAPSULOTOMY WITH YAG LASER</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Olhos de Goiania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Olhos de Goiania</source>
  <brief_summary>
    <textblock>
      Study of refractive changes after capsulotomy with YAG laser in facectomized patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective, quantitative study was carried out by analyzing the medical records of a&#xD;
      reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive&#xD;
      index data were collected from 67 eyes of 66 patients analyzed in the period from May to&#xD;
      November 2016.&#xD;
&#xD;
      We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia&#xD;
      after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10&#xD;
      (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic&#xD;
      mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and&#xD;
      post-capsulotomy of -31.75 D , giving a difference of -2.9 .&#xD;
&#xD;
      It was concluded with this study that the use of posterior capsulotomy with YAG laser post&#xD;
      facectomy caused changes in the refraction of the patients studied, presenting myopia with&#xD;
      greater frequency in the results. With these data, we observed the need for other future&#xD;
      studies with a large number of eyes to prove what happened in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Refractive changes after capsulotomy with YAG laser</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">67</enrollment>
  <condition>Refractive and Accommodative Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We studied 67 eyes of 66 patients , both men and women by analyzing the medical records of&#xD;
        a reference ophthalmologic hospital in Goiás.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Complete data information about refraction and the date of the YAG&#xD;
        laser -&#xD;
&#xD;
        Exclusion Criteria: Incomplete data&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>YAG laser</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993081
org study id: ARVO R1 2017
nct id: NCT02993081
lead sponsor: 
Study of refractive changes after capsulotomy with YAG laser in facectomized patients.
A retrospective, quantitative study was carried out by analyzing the medical records of a
      reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive
      index data were collected from 67 eyes of 66 patients analyzed in the period from May to
      November 2016.

      We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia
      after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10
      (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic
      mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and
      post-capsulotomy of -31.75 D , giving a difference of -2.9 .

      It was concluded with this study that the use of posterior capsulotomy with YAG laser post
      facectomy caused changes in the refraction of the patients studied, presenting myopia with
      greater frequency in the results. With these data, we observed the need for other future
      studies with a large number of eyes to prove what happened in this study.
measure: Refractive changes after capsulotomy with YAG laser
time frame: 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor