Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures
1 other identifier
observational
200
1 country
1
Brief Summary
The aim of the study is to evaluate the degree of refractive error postoperatively in combined procedures and to calculate a new constant in order to improve current state of the art biometry calculations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
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
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMay 2, 2019
April 1, 2019
1.1 years
February 5, 2019
April 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Refractive prediction error (measured by subjective refraction, in diopters)
postoperative actual subjective refraction minus preoperative planned refraction in spherical equivalence (in diopters)
6 weeks postoperatively
Absolute prediction error (measured by subjective refraction, in diopters)
absolute value of the difference between postoperative actual refraction and preoperative planned refraction (in diopters)
6 weeks postoperatively
Changes in Axial Length (measured by biometry, in milimeters)
Change of axial length postoperatively (in milimeter)
6 weeks postoperatively
Changes in corneal curvature (measured by corneal topography, in diopters)
change in corneal curvature (in diopters)
6 weeks postoperatively
Study Arms (1)
Phaco-vitrectomy
Interventions
Biometry for phaco-vitrectomy procedures pre- and postoperatively
Eligibility Criteria
Patients who undergo a combined procedure with phacoemulsification and pars plana vitrectomy
You may qualify if:
- Patients who undergo a combined procedure with phacoemulsification and pars plana vitrectomy
You may not qualify if:
- Sulcus fixation of the IOL, sulcus suture of the IOL, or intra-scleral IOL fixation because of intraoperative posterior capsule rupture
- corneal disease, such as keratoconus, that interfered with refractive results
- IOL implantation with a toric IOL or multifocal IOL
- History of previous vitrectomy or corneal transplantation
- Other coexisting ocular disease such as proliferative diabetic retinopathy, advanced age-related macular degeneration, uveitis, acute retinal necrosis, Coat's disease, proliferative vitreous retinopathy, or trauma
- Intraocular tamponade using silicon oil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cantonal Hospital of Sankt Gallen
Sankt Gallen, 9007, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant ophthalmic surgeon
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 27, 2019
Study Start
June 1, 2019
Primary Completion
June 30, 2020
Study Completion
September 30, 2020
Last Updated
May 2, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share