Quality of Vision in Implantable Collamer Lens (ICL)

Pupil Diameter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982107
• Other study ID #: ICL2020
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2021
• Source: He Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pupil Diameter

Locations

Country	Name	City	State
China	He Eye Specialist Hospital, Shenyang.	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

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