Identification of Minimum Focal Points in Vision Curve Formation
1 other identifier
observational
80
1 country
1
Brief Summary
The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2024
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
Study Start
First participant enrolled
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedMarch 7, 2024
February 1, 2024
6 months
February 7, 2024
March 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Visual curves interpolation
Visual curves interpolation after visual acuity assessment in 9 focal points
6 months
Area of the curve (AOC) assessment
Calculation of the AOC after visual curve interpolation
6 months
Visual acuity assessment
Visual acuity assessment in 9 focal points using DDART chart
6 months
Study Arms (1)
Premium presbyopia surgery
Participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
Interventions
Uncorrected visual acuity for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm) examination via a Democritus Digital Acuity \& Reading Test (DDART).
Eligibility Criteria
participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
You may qualify if:
- age over 40,
- previous bilateral premium cataract surgery,
- best corrected visual acuity (BCVA) \< 0,2 logMAR
You may not qualify if:
- taking topical medication to reduce intraocular pressure (IOP),
- macular diseases,
- corneal diseases,
- inability to understand the procedure,
- postoperative astigmatism \>1.50 diopters,
- postoperative clouding of the posterior capsule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Georgios Labiris, MD, PhD
Democritus University of Thrace
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor (Associate) of Democritus University of Thrace
Study Record Dates
First Submitted
February 7, 2024
First Posted
February 15, 2024
Study Start
February 1, 2024
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
March 7, 2024
Record last verified: 2024-02