Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients
1 other identifier
interventional
62
1 country
1
Brief Summary
The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Typical duration for not_applicable
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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2016
CompletedJune 28, 2017
June 1, 2017
2.6 years
November 21, 2013
June 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Distance-corrected intermediate visual acuity
3 month postop
Secondary Outcomes (10)
Distance-corrected near visual acuity
3 month postop
Uncorrected distance visual acuity
3 month postop
Corrected distance visual acuity
3 month postop
Uncorrected near visual acuity
3 month postop
Corrected near visual acuity
3 month postop
- +5 more secondary outcomes
Study Arms (4)
Hypermetropic, spherical IOL
EXPERIMENTALAMO Sensar AR40e
Hypermetropic, aspheric IOL
EXPERIMENTALAMO Tecnis ZA9003
Emmetropic, spherical IOL
ACTIVE COMPARATORAMO Sensar AR40e
Emmetropic, aspheric IOL
ACTIVE COMPARATORAMO Tecnis ZA9003
Interventions
Eligibility Criteria
You may qualify if:
- Cataract
- Dioptric power of IOL \>22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively
You may not qualify if:
- Uveitis, pathology of the retina or the optic nerve
- Corneal scarring or irregularities
- Astigmatism \>1.5 D
- Amblyopia
- Perioperative complications
- Postoperative refractive error \>2.0 D of spherical equivalent
- Postoperative DCVA \<0.8 (ETDRS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Ophthalmology, Medical University of Graz
Graz, 8036, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Navid Ardjomand, MD
Dept. of Ophthalmology, Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Doz. Dr. med. univ.
Study Record Dates
First Submitted
November 21, 2013
First Posted
November 26, 2013
Study Start
November 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 26, 2016
Last Updated
June 28, 2017
Record last verified: 2017-06