Quality of Vision in Implantable Collamer Lens (ICL)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04982107

Enrollment

Registered

2021-07-29

Start date

2021-07-01

Completion date

2021-09-30

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupil Diameter

Keywords

ICL, QoV, Visual acuity

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Outcome results