CLINICAL TRIAL

Ocufolin for Presbyopia

Recruiting · 18+ · All Sexes · Miami, FL

Clinical Applications of Advanced Ophthalmic Imaging

See full description

About the trial for Presbyopia

Eligible Conditions
Dementia · Dry Eye Syndromes · Diabetic Retinopathy · Presbyopia · Multiple Sclerosis · Myopia

Treatment Groups

This trial involves 2 different treatments. Ocufolin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ocufolin
DIETARYSUPPLEMENT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocufolin
2017
N/A
~30

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Anyone who is capable of imaging can keep their eye open. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ocufolin will improve 5 primary outcomes and 2 secondary outcomes in patients with Presbyopia. Measurement will happen over the course of up to 2 years.

Retinal microstructure using OCT.
UP TO 2 YEARS
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Conjunctival vasculature by functional slit-lamp (FSLB)
UP TO 2 YEARS
Conjunctival vascular network density in percentage.
Corneal epithelial thickness
UP TO 2 YEARS
Measured in micrometers using ultra high resolution OCT
Retinal vasculature by optical coherence tomography angiography (OCTA)
UP TO 2 YEARS
Retinal vascular network density in percentage.
Tear film thickness
UP TO 2 YEARS
Measured in micrometers using ultra high resolution OCT
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
UP TO 2 YEARS
Conjunctival blood flow velocity in mm/s
See More

Who is running the study

Principal Investigator
J. (. W.
Prof. Jianhua (Jay) Wang,, MD PhD
University of Miami

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of presbyopia?

Ocular signs of presbyopia include a change in the refractive power of the eye and/or a change in the shape and/or motility of the eye. Optometric examination for presbyopia is required.

Anonymous Patient Answer

What causes presbyopia?

Findings from a recent study showed a high prevalence of presbyopia in the Saudi population, which suggested that ocular examinations are needed in the early stages of presbyopia and in those over 70 years of age.

Anonymous Patient Answer

How many people get presbyopia a year in the United States?

About 1,500 people in the United States develop presbyopia in a lifetime. The risk, however, of developing presbyopia within the next five years is estimated at nearly 15%.

Anonymous Patient Answer

Can presbyopia be cured?

Presbyopia cannot and should not be cured. To restore presbyopic vision adequately, patients must be able to wear the lenses all of the time. To accomplish this goal, new materials requiring minimal handling and use of artificial lighting are needed; lenses used with rigid, rigid-rigid lenses can be used effectively. Patients must be taught how to use contact lenses.

Anonymous Patient Answer

What are common treatments for presbyopia?

Many patients are currently treated for myopia when they in fact possess a presbyopic refractive state. This issue can adversely affect eye care providers, who usually provide patient education with refractive error information before initiating treatment. Most patients who do not undergo such treatment have an incorrect prescription.

Anonymous Patient Answer

What is presbyopia?

In the USA, presbyopia is one of the most common causes of vision loss in older adults, affecting about 20% of those 65 years and older.

Anonymous Patient Answer

Is ocufolin safe for people?

Ocufolin has not been conclusively identified as safe for use. The risk/benefit profile and the potential for harm may differ from one person to another. To ensure a low cumulative treatment dose and a safe course of treatment, it is important to consider the potential of ocufolin when designing studies for people with retinal disorders.

Anonymous Patient Answer

Does ocufolin improve quality of life for those with presbyopia?

Recent findings has shown a statistically significant improvement in quality of life for ocufolin-treated people with presbyopia. The improvement appears to start about 5 days before the commencement of the ocufolin treatment and is maintained until 7 days after the commencement of ocufolin treatment. Recent findings of this study have shown the significance of taking a systematic, full-scale and comprehensive approach to assess the effect of ocufolin on the quality of life of people with presbyopia. Our observations suggest that ocufolin may be clinically worthwhile.

Anonymous Patient Answer

Have there been any new discoveries for treating presbyopia?

In general, there are not many clinical developments that have had a great deal of success. Recently, the FDA has approved the use of prism (a lens that allows sharper vision) as a cosmetic treatment for moderate to severe myopia. Clinical trials regarding its long-term safety and effectiveness remain to be completed. The eye care team is also trying to find a method to improve vision correction in people with presbyopia and treat it for this reason. It is also important that the prescribing general practitioner is aware of the risks and potential side effects associated with these developments and is careful to follow up.

Anonymous Patient Answer

What are the common side effects of ocufolin?

The common treatment-related side effects were: dizziness, headache, vomiting, rash, and cough. In conclusion, caution is needed when administering ocufolin. In particular, patients with a history or at heightened risk for dehydration or hypotension must be informed of the potential side effects.

Anonymous Patient Answer

What does ocufolin usually treat?

Ocufolin usually treats presbyopia. Ocufolin, by itself, is a drug of limited value and as a monotherapy for presbyopia is not efficacious. Patients receiving ocufolin with LASIK should be followed carefully as the risk of retinal detachment may occur. The combination of LASIK and ocufolin may worsen ocular motility disorders, leading to a postoperative diplopia or myopic shift (in the direction towards the treated eye). Further investigations into the pharmacokinetics of ocufolin in eyes after LASIK are warranted.

Anonymous Patient Answer

Have there been other clinical trials involving ocufolin?

There have been no new clinical trials of ocufolin, a synthetic derivative of vitamin A used as a mydriatic and anti-glare. However, ocufolin has been researched extensively with regard to its effects on eye color, but the results, therefore, are contradictory. In studies involving [retina pigment epithelium (RPE)] cells, ocufolin does increase cell production of retinol, but no effects on the expression of genes related to retinal pigment epithelium cell or function. Therefore, caution must be used to determine in studies that use ocufolin to the effects on gene expression of RPE cells.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Presbyopia by sharing your contact details with the study coordinator.