Trial · NCT07258667
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the efficacy of administering 2 grams per day of nicotinamide for 12 months in patients who have developed NOHL due to an m.11778G>A or m.3460G>A mutation within the last 18 months. | inclusion, 3 months, 6 months, 9 months, and 12 months | Evaluation by the change in corrected distance visual acuity measured eye by eye on an ETDRS (Early Treatment Diabetic Retinopathy Study) scale over the entire follow-up period. |
| Secondary | The effectiveness of treatment on the progression of corrected distance visual acuity | 12 months | Measurement eye by eye using the ETDRS scale, taking the nadir (lowest visual acuity reached a few weeks after the onset of NOHL) as the reference value. |
| Secondary | The effectiveness of treatment on the evolution of corrected distance visual acuity | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement eye by eye on a Monoyer scale. Reading capital letters at a distance of 5 meters. Each line on the wall-mounted optometric chart corresponds to 1/10 of visual acuity.The dimensions of the letters are such that they measure 5 times the distance of discrimination corresponding to the measured visual acuity.0.4/10 is low visual acuity and 20/10 is good visual acuity. |
| Secondary | The effectiveness of treatment on the evolution of corrected near visual acuity | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement eye by eye on a Parinaud scale; different sizes of typeface is placed at 33cm. The test consists of a text whose paragraphs are written in decreasing font sizes. The result is expressed in P (P1.5 to P50). The higher the P, the poorer the acuity. |
| Secondary | The effectiveness of treatment on the evolution of Campimetric deficits | inclusion, 3 months, 6 months, 9 months and 12 months | The average and corrected average deviation measured in STAT 30 on an automated visual field |
| Secondary | The effectiveness of treatment on the evolution of the appearance of visual field | inclusion, 3 months, 6 months, 9 months and 12 months | By the Goldman-type manual |
| Secondary | The effectiveness of treatment on the evolution of optic nerve fiber layer (RNFL) thickness | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement by optical coherence tomography (OCT) |
| Secondary | The effectiveness of treatment on the evolution of retinal ganglion cell complex (GCC) | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement by optical coherence tomography (OCT) |
| Secondary | The effectiveness of treatment on the evolution of Patients' quality of life | inclusion and 12 months | NEI VFQ 25 questionnaire. Individual scores are recoded and transformed on a scale of 0 to 100, where 100 represents the best possible functioning and 0 the worst. An average score is calculated for each of the 12 subscales. |
| Secondary | Biological efficacy of treatment | 3 and 12 months | Nicotinamide levels in patients' blood |
| Secondary | Treatment tolerance on Hepatic toxicity | Inclusion, 3 months, 6 months, 9 months, 12 months | Transaminase levels |
| Secondary | Treatment tolerance in the macula | Inclusion, 3 months, 6 months, 9 months, 12 months | Measurement by optical coherence tomography |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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