NCT01504282

Brief Summary

To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 4, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
Last Updated

January 5, 2012

Status Verified

June 1, 2010

First QC Date

January 4, 2012

Last Update Submit

January 4, 2012

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Central corneal endothelial cell density (ECD) 6 months after the PRK

    6 months

Study Arms (2)

MMC group

ACTIVE COMPARATOR

One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.

Drug: mitomycin-C

BSS group

PLACEBO COMPARATOR

One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.

Drug: Placebo

Interventions

mitomycin-CDRUG
MMC group
PlaceboDRUG

balanced salt solution (BSS)

BSS group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a stable refractive error for at least 1 year
  • corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.

You may not qualify if:

  • Patients with keratoconus suspect,
  • excessive dry eyes,
  • impaired wound healing processes,
  • lenticular changes,
  • corneal dystrophy,
  • history of ocular surgery,
  • anterior or posterior uveitis,
  • glaucoma and retinal diseases were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Myopia

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 5, 2012

Last Updated

January 5, 2012

Record last verified: 2010-06

Locations

IR(1)