Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 31, 2008 | ||||||||||||
| Last Updated Date | January 2, 2009 | ||||||||||||
| Start Date ICMJE | January 2008 | ||||||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Cure rate of recurrent corneal erosions (frequency of attack and numbers of Nd: YAG laser treatment), intensity of pain relief and visual acuity. [ Time Frame: Before treatment, weekly after the treatment, and monthly after symptom relief ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00816738 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser | ||||||||||||
| Official Title ICMJE | Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser | ||||||||||||
| Brief Summary | To evaluate the clinical outcomes in patients with recurrent corneal erosions who received anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser. |
||||||||||||
| Detailed Description | Participants: From 2000 to 2005, thirty-three eyes in 33 patients with unilaterally recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser were studied. Intervention: Anterior corneal stromal puncture with Nd:YAG laser was performed in the loosened epithelium or epithelial defect area. The causes and frequency of corneal erosions and the spot numbers and total energy of the Nd:YAG laser were recorded. Slit-lamp biomicroscopic examination, refraction, corneal topography, and times of laser were reviewed. A questionnaire regarding the preoperative and postoperative difference in the intensity of pain and frequency of corneal erosion was provided. Main Outcome Measures: Rate of recurrence and pain assessment by numerical rating scale. |
||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | to evaluate the clinical outcomes after anterior stromal puncture with Nd:YAG laser in a consecutive series of 33 eyes in 33 patients with unilaterally recurrent corneal erosion. |
||||||||||||
| Condition ICMJE |
|
||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 33 | ||||||||||||
| Completion Date | March 2008 | ||||||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 20 Years to 71 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Taiwan | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00816738 | ||||||||||||
| Other Study ID Numbers ICMJE | 200801035R | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Yu-Chih Hou/Department of Ophthalmology, National Taiwan University Hospital, Organization: Department of Ophthalmology, National Taiwan University Hospital | ||||||||||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | National Taiwan University Hospital | ||||||||||||
| Verification Date | December 2008 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||