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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140046
Other study ID # PRK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date March 1, 2018

Study information

Verified date May 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries .

Spectacle correction is usually not useful in the correction of corneal irregular astigmatism. Contact lenses represent a good alternative, but their adaptation and stability are limited by the irregular corneal surface and patient discomfort.

In recent years, advancements in laser technology have offered better tools for dealing with irregular astigmatism with finding new surgical methods to improve corneal regularity for the correction of irregular astigmatism.

Topography-linked excimer laser is a potentially effective technique in the treatment of irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an effective means of treatment of irregular astigmatism due to different etiologies Such as corneal Injuries , scar , or postoperative.

Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are a better astigmatic correction, the possibility of correcting irregular astigmatism, and a smaller ablation volume compared with standard treatments, resulting in better visual performance.

Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided photorefractive keratectomy (PRK) to improve refractive status of patient with irregular Cornea.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with irregular corneal astigmatism caused by:

- Trauma.

- Non - Central Corneal Scars.

- Previous corneal surgery.

- With No other abnormalities in the eye.

- Patient is willing to enter the study and sign a consent.

Exclusion Criteria:

- Patients with central corneal scars.

- Patients with central haze interfering with visual acuity.

- Patients with ectasia at corneal graft margins.

- Patients with irregular astigmatism caused by corneal ectasia or keratoconus.

- Patients had refractive surgery with ablations leaving a residual corneal thickness less than 250 µm.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
photorefractive keratectomy (PRK)
The cornea will be ablated while the patient fixating on target light under constant eye-tracking control. The ablations will be made using the "ALLEGRETTO X 500WAVE excimer laser" (WaveLight Laser Technologie AG).

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Acuity The measure of the Visual Acuity and Best Corrected Visual acuity Using the Snellen Chart which give use an idea about visual acuity in Metric scale (e.g. 6\6 , 6\12) follow up after 1 day, 1 week, 1 month and 3 months
Secondary Refractive State We will measure the Refractive state of the eye by using the Auto refractor which give us an idea about the refractive state in a Diopteric scale ( e.g. -2D , +4 D) . follow up after 1 day, 1 week, 1 month and 3 months
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