How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure

Sponsor
Medical University of Lodz (Other)
Overall Status
Completed
CT.gov ID
NCT03162471
Collaborator
(none)
39
139

Study Details

Study Description

Brief Summary

The aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (IOP) following micro-incision phacoemulsification.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: non-contact measurement of intraocular pressure

Study Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Impact of Preoperative Astigmatism on Corneal Biomechanics and Accurate Intraocular Pressure Measurement After Micro-incision Phacoemulsification
Actual Study Start Date :
May 1, 2005
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Outcome Measures

Primary Outcome Measures

  1. change of corneal compensated IOP (IOPcc) [Parameter measured preoperatively and one day, one week, one month postoperatively]

    Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.

Secondary Outcome Measures

  1. change of corneal hysteresis (CH) [Parameter measured preoperatively and one day, one week, one month postoperatively]

    Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.

  2. change of corneal resistance factor (CRF) [Parameter measured preoperatively and one day, one week, one month postoperatively]

    Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.

  3. change of Goldman-correlated IOP (IOPg) [Parameter measured preoperatively and one day, one week, one month postoperatively]

    Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.

  4. change of waveform score (WS) [Parameter measured preoperatively and one day, one week, one month postoperatively]

    Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
52 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • diagnosis and qualification for cataract surgery, corneal astigmatism of equal to or less than 2.25 Dcyl
Exclusion Criteria:
  • corneal astigmatism higher than 2.25 Dcyl, history of any other corneal disease (infection, trauma, ulceration, autoimmune inflammation, Fuchs Dystrophy, keratoconus, corneal scars, preoperative insufficiency of corneal endothelium), glaucoma and chronic use of non-glaucoma eye drops, blepharitis, dry eye, use of contact lenses diabetes or a history of corneal refractive surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Lodz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zofia Pniakowska, M.D., Medical University of Lodz
ClinicalTrials.gov Identifier:
NCT03162471
Other Study ID Numbers:
  • RNN/166/17/KE
First Posted:
May 22, 2017
Last Update Posted:
May 22, 2017
Last Verified:
May 1, 2017
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 Zofia Pniakowska, M.D., Medical University of Lodz
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2017