Recurrent Corneal ErosionNCT00816738
Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser
An observational study of Recurrent Corneal Erosion and Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 71 years
- Conditions the study is for
- Recurrent Corneal Erosion, Trauma
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser.
Who cannot join
- Slit-lamp biomicroscopic examination in both eyes of patient showed any evidence of anterior basement membrane dystrophy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Recurrent Corneal Erosion, Trauma
- Keywords
- Nd: YAG laser, recurrent corneal erosions, trauma, anterior stromal puncture
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of recurrent corneal erosions (frequency of attack and numbers of Nd: YAG laser treatment), intensity of pain relief and visual acuity.
Measured: Before treatment, weekly after the treatment, and monthly after symptom relief
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Corneal ErosionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Chih Ho, MD, Study director, National Taiwan University HospitalTzu-Hsun Tsai, MD, Principal investigator, National Taiwan University HospitalTzu-Yun Tsai, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816738
- Sponsor's protocol ID
- 200801035R
- Status last verified
- Dec 2008
- First submitted
- 31 Aug 2008
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser
- ClinicalTrials.gov ID
- NCT00816738
- Acronym / sponsor ID
- 200801035R
- Conditions
- Recurrent Corneal Erosion, Trauma
- Keywords
- Nd: YAG laser, recurrent corneal erosions, trauma, anterior stromal puncture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser.
Key exclusion criteria (1 listed)
- Slit-lamp biomicroscopic examination in both eyes of patient showed any evidence of anterior basement membrane dystrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chih Ho, MD study director
National Taiwan University Hospital
Tzu-Hsun Tsai, MD principal investigator
National Taiwan University Hospital
Tzu-Yun Tsai, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Corneal Erosion and Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2009.