Quality of Vision in Implantable Collamer Lens (ICL)
Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedFirst Posted
Study publicly available on registry
July 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFebruary 1, 2022
July 1, 2021
2 months
January 26, 2021
January 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Eligibility Criteria
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.
You may qualify if:
- Myopic eyes
- Preoperative corneal endothelial cell count ≥2200/mm2
- Preoperative central anterior chamber depth\> 2.80mm
- Intraocular pressure within the normal range (10-21mmHg)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- He Eye Hospitallead
Study Sites (1)
He Eye Specialist Hospital, Shenyang.
Shenyang, Liaoning, 110141, China
Study Officials
- STUDY CHAIR
Wei He
He Eye Specialist Hospital, Shenyang.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2021
First Posted
July 29, 2021
Study Start
July 1, 2021
Primary Completion
August 30, 2021
Study Completion
September 30, 2021
Last Updated
February 1, 2022
Record last verified: 2021-07