Clincosm LogoSign in Get a demo

High Intraocular Pressure After Cataract Surgery

Sponsor
Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05834465
Collaborator
(none)
60
Enrollment
1
Location
3
Anticipated Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To explore the effect of different degrees of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Efficacy Evaluation of Anterior Chamber Drainage in Patients for High Intraocular Pressure After Cataract Surgery
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    After using a non-contact tonometer to measure, the intraocular pressure is reduced by 0-10mmHg.
    Group 2

    After using a non-contact tonometer to measure, the intraocular pressure is reduced by 10-20mmHg.
    Group 3

    After using a non-contact tonometer to measure, the intraocular pressure is reduced over 20mmHg.

    Outcome Measures

    Primary Outcome Measures

    1. The position of IOL through tilt (tilt in degree) [Two hours after cataract surgery (i.e. before anterior chamber drainage)]

      Evaluation of the position of IOL through tilt (tilt in degree)

    2. The position of IOL through decentration (decentration in millimeter) [Two hours after cataract surgery (i.e. before anterior chamber drainage)]

      Evaluation of the position of IOL through decentration (decentration in millimeter)

    3. The position of IOL through tilt (tilt in degree) [Immediately after anterior chamber drainage]

      Evaluation of the position of IOL through tilt (tilt in degree)

    4. The position of IOL through decentration (decentration in millimeter) [Immediately after anterior chamber drainage]

      Evaluation of the position of IOL through decentration (decentration in millimeter)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients over 60 years old who underwent simple age-related cataract surgery in Eye Hospital of Wenzhou Medical University, the operation was successful, and there were no intraoperative complications such as posterior capsule rupture;

    2. Measurements were taken before and after drainage, and all data were complete ;

    3. The patient agrees and accepts the study.

    Exclusion Criteria:

    1. Preoperative glaucoma, ocular hypertension, iritis, uveitis and other eye diseases, as well as other eye diseases and serious systemic diseases that may affect the prognosis of surgery, such as corneal lesions, vitreous volume blood, retinal detachment, poor blood sugar control in diabetes, etc.

    2. Previous history of eye trauma, etc.

    3. Cannot cooperate with the completion of intraocular pressure measurement and CASIA2 examination.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang China

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yune Zhao, Principal Investigator, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT05834465
    Other Study ID Numbers:
    • 20230301CTR
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Capsule Opacification
    Ocular Hypertension

    Study Results

    No Results Posted as of Apr 28, 2023