NCT00917657

Brief Summary

To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

June 9, 2009

Last Update Submit

June 9, 2009

Conditions

Hyperopia

Keywords

photorefractive keratectomyhyperopiaradial keratotomyrefractive surgery

Interventions

Photorefractive keratectomyPROCEDURE

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
  • Uncorrected Visual Acuity of 20/40 or worse;
  • Best-Corrected Visual Acuity of 20/60 or better.

You may not qualify if:

  • Systemic or ocular conditions that could bias results
  • Previous photorefractive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ghanem RC, Ghanem EA, Kara-Jose N. [Safety of photorefractive keratectomy with mitomycin-C for the treatment of hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Mar-Apr;73(2):165-70. doi: 10.1590/s0004-27492010000200013. Portuguese.

    PMID: 20549047DERIVED

  • Ghanem RC, Ghanem EA, Kara-Jose N. [Corneal wavefront-guided photorefractive keratectomy with mitomycin-C for consecutive hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Jan-Feb;73(1):70-6. doi: 10.1590/s0004-27492010000100013. Portuguese.

    PMID: 20464118DERIVED

MeSH Terms

Conditions

Hyperopia

Interventions

Photorefractive Keratectomy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

February 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 10, 2009

Record last verified: 2009-06