Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures

Sponsor
Cantonal Hospital of St. Gallen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03856346
Collaborator
(none)
200
1
16
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Biometry

Detailed Description

The IOL power calculation in combined phaco-vitrectomy has been performed similar to that in cataract surgery alone. In patients who undergo combined phaco-vitrectomy, deviations in refractive outcomes may be observed because of possible errors in measurement of axial length, changes in the properties of the vitreous cavity after removal of the vitreous, or intraocular tamponade. Most of the previous studies have reported variable degrees of myopic shift after phaco-vitrectomy for diabetic retinopathy, epiretinal membrane, and macular hole. Furthermore, use of intraoperative gas may increase further the risk of anterior displacement of the intraocular lens which may induce a higher myopic shift. However, these publications did not provide any quantification of the spherical deviations nor calculate any specific constant in order to improve currents state of art biometry calculations.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures: Calculation of a New Constant for Biometry IOL-formulas
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Phaco-vitrectomy

Diagnostic Test: Biometry
Biometry for phaco-vitrectomy procedures pre- and postoperatively

Outcome Measures

Primary Outcome Measures

  1. Refractive prediction error (measured by subjective refraction, in diopters) [6 weeks postoperatively]

    postoperative actual subjective refraction minus preoperative planned refraction in spherical equivalence (in diopters)

  2. Absolute prediction error (measured by subjective refraction, in diopters) [6 weeks postoperatively]

    absolute value of the difference between postoperative actual refraction and preoperative planned refraction (in diopters)

  3. Changes in Axial Length (measured by biometry, in milimeters) [6 weeks postoperatively]

    Change of axial length postoperatively (in milimeter)

  4. Changes in corneal curvature (measured by corneal topography, in diopters) [6 weeks postoperatively]

    change in corneal curvature (in diopters)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients who undergo a combined procedure with phacoemulsification and pars plana vitrectomy
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cantonal Hospital of Sankt Gallen Sankt Gallen Switzerland 9007

Sponsors and Collaborators

  • Cantonal Hospital of St. Gallen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Josef Guber, Consultant ophthalmic surgeon, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT03856346
Other Study ID Numbers:
  • Phaco-vity-biometry study
First Posted:
Feb 27, 2019
Last Update Posted:
May 2, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Josef Guber, Consultant ophthalmic surgeon, Cantonal Hospital of St. Gallen

Study Results

No Results Posted as of May 2, 2019