Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00564213
Other study ID # BQ -1-07-ARVO
Secondary ID
Status Completed
Phase Phase 4
First received November 26, 2007
Last updated November 25, 2008
Start date March 2005
Est. completion date September 2007

Study information

Verified date November 2007
Source Instituto de Olhos de Goiania
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D).

Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Myopia or compound myopic astigmatism

- Stable refractive error

- No associated eye disease

Exclusion Criteria:

- Diabetes,

- Autoimmune diseases

- Topographic abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Olhos de Goiania
See also
  Status Clinical Trial Phase
Completed NCT01658761 - Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes N/A
Enrolling by invitation NCT03666052 - Shanghai Child and Adolescent Large-scale Eye Study -High Myopia Registration
Completed NCT03294967 - Effect of Caffeine on Ocular Circulation in High Myopes N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A
Not yet recruiting NCT05095194 - Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT N/A
Suspended NCT02915133 - The Relationship Between Structure and Visual Function in Myopia Foveoschisis
Not yet recruiting NCT05533450 - A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens N/A
Not yet recruiting NCT05042856 - To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients N/A
Completed NCT03266354 - Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation
Recruiting NCT05201677 - Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract N/A
Completed NCT02169635 - Macular Buckle With Three-armed Silicone N/A
Recruiting NCT03533647 - Development and Pathological Changes of High Myopia Among Children and Adolescents in China
Completed NCT06204211 - Genetic Research on High Myopic Individuals in Northern China
Active, not recruiting NCT05691296 - The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin N/A
Completed NCT03202485 - Comparison Between TICL and ICL+AK for High Myopic Astigmatism N/A
Not yet recruiting NCT05768152 - Repeated Low-Level Red-Light Therapy Shortens Axial Length N/A
Active, not recruiting NCT05803174 - Screening and Identification of Biomarkers for High Myopia by a Rapid Method
Completed NCT03174639 - High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps N/A
Not yet recruiting NCT06264830 - 3D Visualization System in Highly Myopic Cataract Operation N/A
Recruiting NCT05850936 - Effect of IOP Lowering on Progressive HM N/A