ClinicalTrials.gg
Status unknownNCT00492245Updated Aug 4, 2008

Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

An interventional study of PTK with mitomycin in Adenoviral Opacities in Keratitis and Corneal Opacity, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-08-04.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Read the detailed description

Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.

02

Conditions studied

  • Keratitis
  • Corneal Opacity

Keywords

  • PTK
  • corneal opacity
  • mitomycin
03

In context

Keratitis

108 studies on the registry are indexed under Keratitis; 19 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 70 interventional studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • visual acuity worse than 20/40, caused by central subepithelial fibrosis

Exclusion criteria

Exclusion Criteria:

  • pregnancy, age less than 18 years-old or more than 80 years-old.
  • diabetes, diseases, corneal thickness less tha 400 micron.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • ProcedurePTK with mitomycin in Adenoviral Opacities
06

What researchers measure

Primary outcomes

  1. Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.

    Time frame: one year

Secondary outcomes

  1. wavefront analysis, anterior segment tomography data, corneal biomechanics data.

    Time frame: one year

07

Study locations

1 site
  • Federal University of Sao Paulo
    Sao Paulo, 04145020, Brazil
08

References and documents

Publications

  • Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. doi: 10.1034/j.1600-0420.2003.00015.x. PubMed 12631015 ↗
  • Porges Y, Ben-Haim O, Hirsh A, Levinger S. Phototherapeutic keratectomy with mitomycin C for corneal haze following photorefractive keratectomy for myopia. J Refract Surg. 2003 Jan-Feb;19(1):40-3. doi: 10.3928/1081-597X-20030101-08. PubMed 12553604 ↗
  • Khurana RN, Li Y, Tang M, Lai MM, Huang D. High-speed optical coherence tomography of corneal opacities. Ophthalmology. 2007 Jul;114(7):1278-85. doi: 10.1016/j.ophtha.2006.10.033. Epub 2007 Feb 20. PubMed 17307254 ↗
  • Yamazaki ES, Ferraz CA, Hazarbassanov RM, Allemann N, Campos M. Phototherapeutic keratectomy for the treatment of corneal opacities after epidemic keratoconjunctivitis. Am J Ophthalmol. 2011 Jan;151(1):35-43.e1. doi: 10.1016/j.ajo.2010.07.028. Epub 2010 Nov 24. PubMed 21109229 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2006, a primary completion of May 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2007
First posted
Jun 27, 2007
Start
Apr 2006
Primary completion
May 2008
CompletionEst.
Dec 2008
Last update
Aug 4, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00492245
First posted
Jun 27, 2007
Start date
Apr 2006
Primary completion
May 2008
Completion
Dec 2008 (estimated)
Last update
Aug 4, 2008

Study contacts

Ester S Yamazaki, MD
principal investigator · Federal University of Sao Paulo - Brazil
Mauro S Campos, MD
study chair · Federal University of Sao Paulo - Brazil

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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