Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

Refractive Disorders Clinical Trial

Official title:

Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00599950
• Other study ID #: Cornea 4
• Status: Terminated
• Phase: Phase 4
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).

Description:

10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients ask for PRK surgery

• Patients with stable refraction in the last year

• Patients without systemic and ocular disease

• Patients with 500 microns in pachymetry normal topography

Exclusion Criteria:

• Patients cannot attend their appointments

• Residual, recurrent or active ocular disease

• Previous ocular surgery except PRK

• Autoimmune or connective tissue disease

• Pregnancy

Related Conditions & MeSH terms

• Refractive Disorders
• Refractive Errors

Intervention

Drug:
• Mitomycin C and Photorefractive keratectomy (PRK)
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

Locations

Country	Name	City	State
Mexico	Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".	Mexico city	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Ghirlando A, Gambato C, Midena E. LASEK and photorefractive keratectomy for myopia: clinical and confocal microscopy comparison. J Refract Surg. 2007 Sep;23(7):694-702. doi: 10.3928/1081-597X-20070901-08. — View Citation

Midena E, Gambato C, Miotto S, Cortese M, Salvi R, Ghirlando A. Long-term effects on corneal keratocytes of mitomycin C during photorefractive keratectomy: a randomized contralateral eye confocal microscopy study. J Refract Surg. 2007 Nov;23(9 Suppl):S1011-4. doi: 10.3928/1081-597X-20071102-06. — View Citation

Ying L, Xiao Z, Liuxueying Z, Yumei J. Clinical use of in vivo confocal microscopy through focusing in corneal refractive surgery. J Refract Surg. 2006 Nov;22(9 Suppl):S1041-6. doi: 10.3928/1081-597X-20061102-07. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)		Before surgery and 1 week, 1 month, 3 months, 6 months after surgery