Quality of Vision in Implantable Collamer Lens (ICL)

January 29, 2022 updated by: He Eye Hospital

Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)

The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110141
        • He Eye Specialist Hospital, Shenyang.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Randomly choosen patients from the hospital records who had ICL surgery at He Eye Hospital, Shenyang, China during September 2019 to September 2020. They must have signed informed consent for their records to be used for education and research purposes before undergoing ICL surgery for myopic correction.

Description

Inclusion Criteria:

  • Myopic eyes
  • Preoperative corneal endothelial cell count ≥2200/mm2
  • Preoperative central anterior chamber depth> 2.80mm
  • Intraocular pressure within the normal range (10-21mmHg)

Exclusion Criteria:

  • Severe dry eye
  • Cataract and glaucoma
  • Patients with uveitis
  • Retinal detachment
  • Patients with autoimmune diseases
  • Patients with systemic diseases such as diabetes and hypertension
  • Patients with mental or cognitive abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Quality of vision
Time Frame: Baseline (before surgery) and 3 month after surgery
Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements
Baseline (before surgery) and 3 month after surgery
Pupil diameter pre-operation and post-operation
Time Frame: Baseline (before surgery) and 3 month after surgery
Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements
Baseline (before surgery) and 3 month after surgery
Wave front aberrometry
Time Frame: baseline and 3 month after surgery
Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements
baseline and 3 month after surgery
Point Spread Function (PSF)
Time Frame: baseline and 3 month after surgery
Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements
baseline and 3 month after surgery
Strehl ratio
Time Frame: Baseline and 3 month after surgery
Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements
Baseline and 3 month after surgery
Modulation transfer function (MTF)
Time Frame: Baseline and 3 month after surgery
Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements
Baseline and 3 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Wei He, He Eye Specialist Hospital, Shenyang.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 29, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICL2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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