Quality of Vision in Implantable Collamer Lens (ICL)

Completed

• Conditions: Pupil Diameter

• Registration Number: NCT04982107
• Lead Sponsor: He Eye Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-26
• Status Verified: 2021-07
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-30
• Last Update Submitted: 2022-01-29
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

He Eye Specialist Hospital, Shenyang.; 🇨🇳 Shenyang, Liaoning, China