Trial · NCT01893359
Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
NCT01893359, Phase 1, Phase 2, Terminated, Glaukos Corporation; results first posted 2016-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism. Trials, record NCT01893359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01893359
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
- NCT number
- NCT01893359
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Glaukos Corporation
- Conditions
- Hyperopia, Hyperopic Astigmatism
- Interventions
riboflavin ophthalmic solution, 0% dextran, UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA), UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off), Laser-assisted in situ keratomileusis
- First posted
- 2013-07-09
- Last updated
- 2021-04-26
- Results first posted
- 2016-10-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MRSE Regression | one week to six months | The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months. |
| Primary | MRSE Regression | one week to twelve months | The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MRSE Regression | one week to six months | This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. Data for MSRE were collected for the two treated patients the primary endpoint is a comparison between the treatment groups. The two patients were in the same treatment group so a comparison between groups is not possible. | ||
| PRIMARY | MRSE Regression | one week to twelve months | This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LASIK Followed by Cross-linking (Continuous Wave) | 0 | |
| Overall Study | STARTED | LASIK Followed by Cross-linking (Pulsed) | 2 | |
| Overall Study | STARTED | LASIK Only | 0 | |
| Overall Study | COMPLETED | LASIK Followed by Cross-linking (Continuous Wave) | 0 | |
| Overall Study | COMPLETED | LASIK Followed by Cross-linking (Pulsed) | 2 | |
| Overall Study | COMPLETED | LASIK Only | 0 | |
| Overall Study | NOT COMPLETED | LASIK Followed by Cross-linking (Continuous Wave) | 0 | |
| Overall Study | NOT COMPLETED | LASIK Followed by Cross-linking (Pulsed) | 0 | |
| Overall Study | NOT COMPLETED | LASIK Only | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | LASIK Followed by Cross-linking (Continuous Wave) | 0 | 0 | 0 |
| other | Vision blurred | Eye disorders | LASIK Followed by Cross-linking (Pulsed) | 1 | 2 | 2 |
| other | Vision blurred | Eye disorders | LASIK Only | 1 | 2 | 1 |
| other | Foreign body sensation in eye | Eye disorders | LASIK Followed by Cross-linking (Continuous Wave) | 0 | 0 | 0 |
| other | Foreign body sensation in eye | Eye disorders | LASIK Followed by Cross-linking (Pulsed) | 1 | 2 | 1 |
| other | Foreign body sensation in eye | Eye disorders | LASIK Only | 1 | 2 | 1 |
| other | Photophobia | Eye disorders | LASIK Followed by Cross-linking (Continuous Wave) | 0 | 0 | 0 |
| other | Photophobia | Eye disorders | LASIK Followed by Cross-linking (Pulsed) | 1 | 2 | 1 |
| other | Photophobia | Eye disorders | LASIK Only | 1 | 2 | 1 |
| other | Conjunctival hyperaemia | Eye disorders | LASIK Followed by Cross-linking (Continuous Wave) | 0 | 0 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LASIK Followed by Cross-linking (Continuous Wave) | ||
| Total, all-cause mortality | LASIK Followed by Cross-linking (Pulsed) | ||
| Total, all-cause mortality | LASIK Only | ||
| Total, other adverse events | LASIK Followed by Cross-linking (Continuous Wave) | 0 | 0 |
| Total, other adverse events | LASIK Followed by Cross-linking (Pulsed) | 2 | 2 |
| Total, other adverse events | LASIK Only | 2 | 2 |
| Total, serious adverse events | LASIK Followed by Cross-linking (Continuous Wave) | 0 | 0 |
| Total, serious adverse events | LASIK Followed by Cross-linking (Pulsed) | 0 | 2 |
| Total, serious adverse events | LASIK Only | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01893359
GET https://conductscience.org/api/trials/v1/NCT01893359/events?page=2