Recurrent Corneal ErosionsPhase 4PTK x CENCT01251692
Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions
A Phase 4 study testing Surgery in people with Recurrent Corneal Erosions, run by Instituto de Olhos de Goiania.
Trial summary
To determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Corneal Erosions
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 1996to Jan 2010
- Phase
- Phase 4
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed
Who cannot join
- Diabetes
- Autoimmune diseases
About this study
Official title: Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions
To determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions.
Read the detailed description
A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years).
- Conditions
- Recurrent Corneal Erosions
- Being tested
- Surgery
- Keywords
- Corneal erosions, PTK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years). Receives: Procedure: Surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJan 1996
- Primary completionJan 2000
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Corneal ErosionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Investigators
- Belquiz A Nassaralla, Study chair, Instituto de Olhos de Goiânia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251692
- Sponsor's protocol ID
- BQ-1-10-ARVO
- Acronym
- PTK x CE
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions
- ClinicalTrials.gov ID
- NCT01251692
- Acronym / sponsor ID
- PTK x CE / BQ-1-10-ARVO
- Conditions
- Recurrent Corneal Erosions
- Keywords
- Corneal erosions, PTK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Jan 1996
- Primary completion
- Jan 2000 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Dec 2010 (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 determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions.
Detailed description
A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: SurgeryA retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed
Key exclusion criteria (2 listed)
- Diabetes
- Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryThe corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
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 2 Dec 2010.
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.
Belquiz A Nassaralla study chair
Instituto de Olhos de Goiânia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgery in people with Recurrent Corneal Erosions, run by Instituto de Olhos de Goiania.
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 2 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 2 Dec 2010; AzTrials last refreshed its copy on 8 Nov 2026.