Treatment for Keratoconus

Phase-Based Estimates
Hôpital Maisonneuve-Rosemont, Montréal, Canada
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether a drug called mitomycin C can reduce corneal haze and scarring after corneal crosslinking.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Keratoconus. Measurement will happen over the course of 18 months post-operation.

Month 18
Clinical haze grade
Higher-order aberrations
18 months post-operation
Corneal haze/scarring

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

CXL with MMC
Placebo group

This trial requires 64 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. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

CXL with MMC
Patients who have undergone corneal cross-linking (CXL) with the application of Mitomycin C (MMC).
CXL without MMC
Patients who have undergone corneal cross-linking (CXL) without the application of Mitomycin C (MMC).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 month, 3 months, 6 months, 12 months and 18 months post-operation. for reporting.

Closest Location

Hôpital Maisonneuve-Rosemont - Montréal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients from both genders with confirmed keratoconus with evidence of clinical and topographic progression.
Patients with the diagnosis of other ectatic disorders such as post refractive surgery ectasia with evidence of clinical and topographic progression.

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 common treatments for keratoconus?

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There is no cure for [keratoconus]( so treatment is focused on the patient and is highly dependent on the specific patient. Patients may benefit from education about the disease and its natural history. Keratoconus and cornea transplant is a rare but effective treatment for keratoconus patients.

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What are the signs of keratoconus?

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Keratoconus is characterized by the appearance of keratologic changes (e.g. corneal transparency), epithelial thinning of the cornea's tear film layer, deposition of protein in the corneal stroma, and corneal vascularization.

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What causes keratoconus?

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The prevalence of keratoconus was 2.6:1,000 for eyes with an unroofed posterior chamber and 6.9:1,000 for eyes with a totally opaque anterior chamber. All cases of keratoconus in patients without corneal trauma were associated with unroofed posterior lenses or complete corneal grafts to the eyeball. The prevalence of keratoconus was lower in dark-skinned subjects than in Caucasians (0.54:1,000 vs. 0.70:1,000), but the association of this eye condition with uveitis was more notable in dark-skinned subjects (0.54:1,000 vs 0.20:1,000).

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

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Between 1 and 2.8 million children across the US will be diagnosed with Keratoconus by the year 2018, a significant portion arising from late teens and early twenties. It is predicted that an extra 1.4 million American children will be diagnosed with Keratoconus by 2036, resulting in about 2.5 million children.

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Can keratoconus be cured?

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It is not possible to heal keratoconus. People who have keratoconus should continue to wear contact lenses or eyeglasses at all times. When contact lenses become painful or if they become excessively damp, they should be washed and worn for a short period of time. Contact lenses should also be replaced when worn out.

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What is keratoconus?

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Keratoconus is the result of severe distortion of the cornea, causing it to become conic. If left untreated, keratoconus can cause blindness.\n\nBabies and toddlers usually do not have the full set of teeth that adults need to chew solid foods. A baby is able to begin eating solid foods when the canines, premolars, and molars are present. These teeth usually develop at different times during a baby's life depending on the baby's age. Dental care may be required by the time the first set of permanent teeth are coming in.\n\nTooth brushing can be done at any time. The routine visits to the dentist often include checks for gum irritation.

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How serious can keratoconus be?

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Keratoconus is a highly stigmatized condition and individuals with the disease experience social pressures to hide their condition on first coming to eye care services. This may contribute to the higher number of keratoconus patients who fail to seek definitive surgical intervention, which could lead to serious damage to the eyes. However, it has been reported that vision is good in the most severe cases of keratoconus. This emphasizes the fact that keratoconus is a highly treatable disease and the main goal of proper timely diagnosis is to prevent permanent loss of vision.

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Is treatment typically used in combination with any other treatments?

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The authors' results confirm the effectiveness of a stepwise approach with initial intacs and soft lens correction, and with combined intacs and soft lens followed by corneal crosslinking. In view of the relatively low number of patients, the authors should be cautious with the conclusion of this preliminary study.

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Have there been any new discoveries for treating keratoconus?

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The use of adeno-associated virus mediated delivery of the transforming growth factor beta1(TGF-beta1) with a ciliary membrane protein(CMP) or the PAS-L-CD80 fusion protein, both of which are in the early stage of being explored as therapies for keratoconus, has the potential to lead to a new therapy and lessen corneal tissue damages caused by this chronic disease. It will also provide great aid in preventing the development of complications like corneal scarring and corneal opacities, glaucoma, and loss of corneal transparency.

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Have there been other clinical trials involving treatment?

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I feel a thorough investigation into the best treatment option before adopting CCT is essential to a clear understanding in improving postoperative vision recovery, especially after corneal refractive surgery with corneal ablation.

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How does treatment work?

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The use of the excimer laser has revolutionized treatment of keratoconus by inducing remission and preventing progression. In comparison to traditional photocoagulation, the combined photorefractive keratectomy (PKR) and LASIK can also produce results with comparable efficacy, although the efficacy decreases as age increases. Treatment of keratoconus was found to be effective and to maintain long-term correction.

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What are the latest developments in treatment for therapeutic use?

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LASIK is still the preferred method of treating [keratoconus]( up to the last decade. But as it's becoming more and more commonly used, as it has a high rate of success in treating the condition, other approaches have been explored. There are many new approaches in treating keratoconus, the aim being to achieve a healthier cornea with a more predictable biomechanical behaviour, thus allowing for better visual outcome.

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