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CompletedNCT04982107Updated Feb 1, 2022

Quality of Vision in Implantable Collamer Lens (ICL)

An observational study in Pupil Diameter, sponsored by He Eye Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by He Eye Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pupil Diameter

Keywords

  • ICL
  • QoV
  • Visual acuity
03

In context

Lead sponsor

He Eye Hospital is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Subjective Quality of vision

    Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements

    Time frame: Baseline (before surgery) and 3 month after surgery

  2. Pupil diameter pre-operation and post-operation

    Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements

    Time frame: Baseline (before surgery) and 3 month after surgery

  3. Wave front aberrometry

    Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements

    Time frame: baseline and 3 month after surgery

  4. Point Spread Function (PSF)

    Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements

    Time frame: baseline and 3 month after surgery

  5. Strehl ratio

    Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements

    Time frame: Baseline and 3 month after surgery

  6. Modulation transfer function (MTF)

    Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements

    Time frame: Baseline and 3 month after surgery

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Study locations

1 site
  • He Eye Specialist Hospital, Shenyang.
    Shenyang, Liaoning 110141, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04982107
Lead sponsor
He Eye Hospital
Responsible party
Sponsor
First posted
Jul 29, 2021
Start date
Jul 1, 2021
Primary completion
Aug 30, 2021
Completion
Sep 30, 2021
Last update
Feb 1, 2022

Study contacts

Wei He
study chair · He Eye Specialist Hospital, Shenyang.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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