Trial · NCT01769352
Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
NCT01769352, Phase 2, Phase 3, Completed, Johns Hopkins University; results first posted 2017-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1). Trials, record NCT01769352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01769352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
- NCT number
- NCT01769352
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Post-surgical Cystoid Macular Edema (PSCME)
- Interventions
- PredA + Kelac
- First posted
- 2013-01-16
- Last updated
- 2017-09-15
- Results first posted
- 2017-09-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Baseline and Week 12 | Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision. |
| Secondary | Mean Change in Central Subfield Thickness at Week 12 From Baseline | Baseline and Week 12 | Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline |
| Secondary | Mean Change in Intraocular Pressure at Week 12 From Baseline | Baseline and Week 12 | Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline |
| Secondary | Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 | Week 12 and Week 48 | Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision. |
| Secondary | Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 | Week 12 and Week 48 | Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48 |
| Secondary | Mean Change in Intraocular Pressure Between Week 12 and Week 24 | Week 12 and Week 48 | Mean Change in Intraocular Pressure (IOP) between week 12 and week 24 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Baseline and Week 12 | letters | MEAN | |
| SECONDARY | Mean Change in Central Subfield Thickness at Week 12 From Baseline | Baseline and Week 12 | µm | MEAN | |
| SECONDARY | Mean Change in Intraocular Pressure at Week 12 From Baseline | Baseline and Week 12 | mmHg | MEAN | |
| SECONDARY | Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 | Week 12 and Week 48 | Letters | MEAN | |
| SECONDARY | Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 | Week 12 and Week 48 | µm | MEAN | |
| SECONDARY | Mean Change in Intraocular Pressure Between Week 12 and Week 24 | Week 12 and Week 48 | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Post-Cataract Surgery Macular Edema- Group 1 | 10.6 | Standard Error 2.6 | letters | |
| Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Post-Cataract Surgery Macular Edema- Group 2 | 7.8 | Standard Error 3.4 | letters | |
| Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Post-Other Surgery Macular Edema- Group 1 | 13.1 | Standard Error 3.4 | letters | |
| Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Post-Other Surgery Macular Edema- Group 2 | 9.4 | Standard Error 3.6 | letters | |
| Mean Change in Central Subfield Thickness at Week 12 From Baseline | Post-Cataract Surgery Macular Edema- Group 1 | -152.7 | Standard Error 33.5 | µm | |
| Mean Change in Central Subfield Thickness at Week 12 From Baseline | Post-Cataract Surgery Macular Edema- Group 2 | -56.4 | Standard Error 21.0 | µm | |
| Mean Change in Central Subfield Thickness at Week 12 From Baseline | Post-Other Surgery Macular Edema- Group 1 | -25.9 | Standard Error 25.7 | µm | |
| Mean Change in Central Subfield Thickness at Week 12 From Baseline | Post-Other Surgery Macular Edema- Group 2 | -75.0 | Standard Error 30.7 | µm | |
| Mean Change in Intraocular Pressure at Week 12 From Baseline | Post-Cataract Surgery Macular Edema- Group 1 | 2.6 | Standard Error 1.2 | mmHg | |
| Mean Change in Intraocular Pressure at Week 12 From Baseline | Post-Cataract Surgery Macular Edema- Group 2 | 3.3 | Standard Error 1.4 | mmHg |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1 | 13 | |
| Overall Study | STARTED | Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2 | 12 | |
| Overall Study | STARTED | Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1 | 9 | |
| Overall Study | STARTED | Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2 | 8 | |
| Overall Study | COMPLETED | Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1 | 13 | |
| Overall Study | COMPLETED | Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2 | 12 | |
| Overall Study | COMPLETED | Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1 | 9 | |
| Overall Study | COMPLETED | Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2 | 8 | |
| Overall Study | NOT COMPLETED | Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1 | 0 | |
| Overall Study | NOT COMPLETED | Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
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 | Increase in Intraocular Pressure | Eye disorders | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 3 | 22 | 3 |
| other | Increase in Intraocular Pressure | Eye disorders | Prednisolone Acetate Four Times a Day (Group 2) | 5 | 20 | 5 |
| other | Upper Respiratory Tract Infections | Respiratory, thoracic and mediastinal disorders | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 3 | 22 | 3 |
| other | Upper Respiratory Tract Infections | Respiratory, thoracic and mediastinal disorders | Prednisolone Acetate Four Times a Day (Group 2) | 4 | 20 | 4 |
| serious | Retinal Detachment | Eye disorders | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 1 | 22 | 1 |
| serious | Retinal Detachment | Eye disorders | Prednisolone Acetate Four Times a Day (Group 2) | 0 | 20 | 0 |
| serious | Endophthalmitis | Eye disorders | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 1 | 22 | 1 |
| serious | Endophthalmitis | Eye disorders | Prednisolone Acetate Four Times a Day (Group 2) | 0 | 20 | 0 |
| serious | Blood transfusion due to severe anemia | Blood and lymphatic system disorders | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 1 | 22 | 1 |
| serious | Blood transfusion due to severe anemia | Blood and lymphatic system disorders | Prednisolone Acetate Four Times a Day (Group 2) | 0 | 20 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 0 | 22 |
| Total, all-cause mortality | Prednisolone Acetate Four Times a Day (Group 2) | 0 | 20 |
| Total, other adverse events | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 6 | 22 |
| Total, other adverse events | Prednisolone Acetate Four Times a Day (Group 2) | 9 | 20 |
| Total, serious adverse events | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | 5 | 22 |
| Total, serious adverse events | Prednisolone Acetate Four Times a Day (Group 2) | 4 | 20 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prednisolone Acetate Every 1 Hour While Awake (Group 1) vs Prednisolone Acetate Four Times a Day (Group 2): deaths from any cause | Trial comparisons |
| Prednisolone Acetate Every 1 Hour While Awake (Group 1) vs Prednisolone Acetate Four Times a Day (Group 2): 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/NCT01769352
GET https://conductscience.org/api/trials/v1/NCT01769352/results?page=2