Treatment for Keratoconus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cornea and Laser Eye Institute, Hersh Vision Group, Teaneck, NJ
Keratoconus+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new method of corneal crosslinking may be more effective than standard CXL.

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Eligible Conditions

  • Keratoconus
  • Ectasia Corneal

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Keratoconus. Measurement will happen over the course of 6 months.

6 months
Maximum keratometry
Mean keratometry

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Pulsed UVA
1 of 2
Continuous UVA
1 of 2
Active Control

This trial requires 170 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Pulsed UVA
Drug
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time
Continuous UVA
Drug
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Cornea and Laser Eye Institute, Hersh Vision Group - Teaneck, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
Presence of central or inferior corneal steepening on the Pentacam map
Axial topography consistent with keratoconus or post-surgical corneal ectasia
Contact lens wearers only: removal of contact lenses for the required period of 1 week prior to the screening refraction
Willingness and ability to comply with schedule for follow-up visits
Signed written informed consent

Patient Q&A Section

What are the signs of keratoconus?

"Signs of keratoconus include bulleting and thinning of the cornea. They can be distinguished from those of corneal infections that may cause the same signs. The most accurate diagnostic means, however, is contact lens fit." - Anonymous Online Contributor

Unverified Answer

What causes keratoconus?

"Keratoconus is estimated to affect more than 3% of the US population. In children with keratoconus and/or atopic dermatitis, it is likely familial. It is unclear whether keratoconus is caused by a genetic defect or whether the disease is an indicator for other disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for keratoconus?

"The only effective remedy to treat keratoconus at the time of diagnosis is corneal transplant surgery. The likelihood of achieving a good visual outcome is not very high, but, even in keratoconus cases, corneal transplant surgery does produce long-term visual improvements, which can be substantial for some patients. The visual improvements after keratoconus surgery are not complete, but they are sufficient to support some lifestyle changes to help minimize corneal damage or progression." - Anonymous Online Contributor

Unverified Answer

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

"Each year, around 2.5 million to three million US adults are diagnosed with keratoconus. Keratoconus affects one out of every 1,000 people. The disease was originally termed keratoconus because of its first presentation in the cornea when it was initially described by German ophthalmologist Karl Friedrich Schonlein in 1886." - Anonymous Online Contributor

Unverified Answer

What is keratoconus?

"Keratoconus is a chronic disease that most commonly affects the cornea or corneal surface and often causes visual deterioration, but in approximately 90% of cases it is asymptomatic. No satisfactory treatment exists for keratoconus. There are many misconceptions regarding keratoconus, and the condition is still relatively unknown to the general public." - Anonymous Online Contributor

Unverified Answer

Can keratoconus be cured?

"As some cases of keratoconus show different results depending on the type and severity of the disease, it is important to have a complete and differential history to determine the optimal therapy approach for each situation." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"There is no standard treatment. Treatment will depend on the presentation of the disease. In general, the goal of treatment is to prevent progression of the disease. In patients with keratoconus and corneal scars from corneal surgery, the keratoconus itself is treated. The scars are reattached, or debrided with small incisions, so that the corneal surface is as smooth as possible. Other treatments include medications which decrease corneal edema and pain, or medications which alter collagen type I, a protein which plays an important role in the formation of corneal collagen." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of keratoconus?

"There is no one theory that can explain the development of keratoconus. However, a predisposition towards keratoconus within certain families seems to have run in the family. Keratoconus in our family seems to be inherited in an autosomal dominant mode. This inheritance seems to run in the same family. The fact that the father hasn’t had keratoconus nor the other eye has had it, supports our thinking that there has to be some genetic defect." - Anonymous Online Contributor

Unverified Answer

How serious can keratoconus be?

"Keratoconus will progress with myopia with time. While the loss of vision is still not serious in mild cases, it surely will lead to a complete blindness. I will never be the same person I used to be." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"There is usually some recovery of vision with treatment. In many cases corneal transplantation is recommended and it is the only option. For more severe cases, corneal grafts are not a perfect option. The choice of surgery will be dictated by the experience and wishes of the surgeon. Treatment is usually successful in the short term. The overall patient outcome is good. Eye damage is significant, and eye damage related to refractive surgery is usually permanent. For people with myopia, a successful operation may increase the chances of success of corrective surgery of myopia. However, surgery alone does not guarantee clear vision; vision needs to be maintained through other treatments." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating keratoconus?

"In spite of multiple new developments in keratoconus, there is no conclusive answer as to how this disease will be treated in the near future. Nevertheless, recent advances include the use of corneal cross linking to stabilize corneal surface irregularities in order to reduce progressive deterioration in visual acuity due to keratoconus. As mentioned above, this procedure has gained greater acceptance in recent years due to recent studies showing that in the long term CXL can halt progression and improves long-term outcome. Nevertheless, a high percentage of patients will need to undergo additional corneal lamellar surgeries or keratomileusis to stabilize their vision over time." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"Keratoprosthesis is currently the first-line treatment for keratoconus, but its role is lessened in the United States in favour of corneal transplantation in select patients. Some reports have shown keratoprosthesis is a safe and effective option in the management of keratoconus, especially for the management of the corneal instability associated with the condition. There is increasing evidence supporting the use of keratoprosthesis in keratoconus and its ability to provide pain relief as well as better vision in moderate or profound keratoconus. Keratoconus is rare, with an incidence between 1:2000-1:5000 in the United States." - Anonymous Online Contributor

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