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Completed

NCT Number: NCT04982107

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.

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Key information

Conditions

Pupil Diameter

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

He Eye Specialist Hospital, Shenyang.

Shenyang, Liaoning, 110141, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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