Trial · NCT01143389
Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
NCT01143389, Phase 2, Completed, Price Vision Group; results first posted 2018-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia. Trials, record NCT01143389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01143389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
- NCT number
- NCT01143389
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 510 participants, actual
- Lead sponsor
- Price Vision Group
- Conditions
- Keratoconus, Post-Refractive Ectasia
- Interventions
- Riboflavin, UVX light
- First posted
- 2010-06-14
- Last updated
- 2018-06-06
- Results first posted
- 2018-05-04
- Limitations and caveats
- Limitations included the 6-month follow up duration and the reduced reproducibility of measurement techniques in eyes with ectasia as compared with normal eyes.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Maximum Keratometry From Baseline to 6 Months After Treatment | 6 months | Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography. |
| Secondary | Pachymetry | 6 months | Minimum corneal thickness measured by corneal tomography |
| Secondary | Corrected Distance Visual Acuity (CDVA) | 6 months | Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart. |
| Secondary | Uncorrected Distance Visual Acuity (UDVA) | 6 months | Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Maximum Keratometry From Baseline to 6 Months After Treatment | 6 months | Per protocol population | diopters | MEAN |
| SECONDARY | Pachymetry | 6 months | Per protocol | microns | MEAN |
| SECONDARY | Corrected Distance Visual Acuity (CDVA) | 6 months | Per protocol | logMAR | MEAN |
| SECONDARY | Uncorrected Distance Visual Acuity (UDVA) | 6 months | Per protocol | logMAR | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Maximum Keratometry From Baseline to 6 Months After Treatment | Riboflavin 0.1% Eyedrops Every 5 Minutes | 0.76 | Standard Deviation 2.4 | diopters | |
| Change in Maximum Keratometry From Baseline to 6 Months After Treatment | Riboflavin 0.1% Eyedrops Every 2 Minutes | 0.97 | Standard Deviation 3.2 | diopters | |
| Pachymetry | Riboflavin 0.1% Eyedrops Every 5 Minutes | 438 | Standard Deviation 51 | microns | |
| Pachymetry | Riboflavin 0.1% Eyedrops Every 2 Minutes | 434 | Standard Deviation 20 | microns | |
| Corrected Distance Visual Acuity (CDVA) | Riboflavin 0.1% Eyedrops Every 5 Minutes | 0.32 | Standard Deviation 0.29 | logMAR | |
| Corrected Distance Visual Acuity (CDVA) | Riboflavin 0.1% Eyedrops Every 2 Minutes | 0.31 | Standard Deviation 0.28 | logMAR | |
| Uncorrected Distance Visual Acuity (UDVA) | Riboflavin 0.1% Eyedrops Every 5 Minutes | 0.95 | Standard Deviation 0.53 | logMAR | |
| Uncorrected Distance Visual Acuity (UDVA) | Riboflavin 0.1% Eyedrops Every 2 Minutes | 0.91 | Standard Deviation 0.55 | logMAR |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riboflavin 0.1% Eyedrops Every 5 Minutes | 253 | |
| Overall Study | STARTED | Riboflavin 0.1% Eyedrops Every 2 Minutes | 257 | |
| Overall Study | COMPLETED | Riboflavin 0.1% Eyedrops Every 5 Minutes | 227 | |
| Overall Study | COMPLETED | Riboflavin 0.1% Eyedrops Every 2 Minutes | 232 | |
| Overall Study | NOT COMPLETED | Riboflavin 0.1% Eyedrops Every 5 Minutes | 26 | |
| Overall Study | NOT COMPLETED | Riboflavin 0.1% Eyedrops Every 2 Minutes | 25 |
Source ClinicalTrials.gov
Adverse events2
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 | Loss of 2 or more logMAR lines of corrected distance visual acuity (CDVA) relative to baseline | Eye disorders | Riboflavin 0.1% Eyedrops Every 5 Minutes | 12 | 253 | 12 |
| other | Loss of 2 or more logMAR lines of corrected distance visual acuity (CDVA) relative to baseline | Eye disorders | Riboflavin 0.1% Eyedrops Every 2 Minutes | 13 | 257 | 13 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riboflavin 0.1% Eyedrops Every 5 Minutes | 0 | 253 |
| Total, all-cause mortality | Riboflavin 0.1% Eyedrops Every 2 Minutes | 0 | 257 |
| Total, other adverse events | Riboflavin 0.1% Eyedrops Every 5 Minutes | 12 | 253 |
| Total, other adverse events | Riboflavin 0.1% Eyedrops Every 2 Minutes | 13 | 257 |
| Total, serious adverse events | Riboflavin 0.1% Eyedrops Every 5 Minutes | 0 | 253 |
| Total, serious adverse events | Riboflavin 0.1% Eyedrops Every 2 Minutes | 0 | 257 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riboflavin 0.1% Eyedrops Every 5 Minutes vs Riboflavin 0.1% Eyedrops Every 2 Minutes: deaths from any cause | Trial comparisons |
| Riboflavin 0.1% Eyedrops Every 5 Minutes vs Riboflavin 0.1% Eyedrops Every 2 Minutes: serious adverse events | Trial comparisons |
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/NCT01143389
GET https://conductscience.org/api/trials/v1/NCT01143389/registered