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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05812508
Other study ID # Soh-Med-22-10-02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 20, 2023
Est. completion date October 1, 2023

Study information

Verified date April 2023
Source Sohag University
Contact Zeinab Mahmoud Aly, bechlor
Phone 01224483318
Email drzeinabmahmoud32@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Aim of the work: To study the corneal topographic pattern changes in patients who have pterygium excision by two surgical techniques (bare sclera, conjunctival autograft).


Description:

Pterygium is one of the common ocular surface disorders , it's is an elastotic triangular fibro-vascular tissue covered by conjunctival epithelium that spreads over the cornea. Pterygium causes differences in curvature & power across the cornea . The prevalence of pterygium varies from 1.1% to 53% globally in different environmental conditions. Risk factors include;UV radiation, geographical latitude near to the equator, outdoor activity , aging, male, and dusty environment. Pterygium excision is important in patients suffering from blurred vision due to astigmatism . Surgical techniques include ; bare sclera excision, conjunctival autograft, conjunctival transpositional flap, and amniotic membrane grafting. Pterygium excision increases in the mean central corneal curvature & reduces astigmatism that leads to improvement in visual acuity. Corneal topography is a gold standard in corneal pathology follow-up. Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Corneal topography produces a detailed, visual description of the shape and power of the cornea. In this study , corneal topography is used to detect how does corneal curvature change after excision of pterygium .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date October 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:- - Patients with pterygium not associated with other pathologies (suitable for excision). - Nasal pterygium extended to the cornea. Exclusion Criteria: - - Associated pathologies such as glaucoma, and cataract. - Corneal opacities or irregularities, scars, dystrophy or ectasia. - Patients who underwent previous corneal surgery (including refractive surgery) - Pseudo-pterygium.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
corneal topography
corneal topography before and after pterygium surgery by two techniques bare scleral and conjunctival autograft

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (1)

Yilmaz S, Yuksel T, Maden A. Corneal topographic changes after four types of pterygium surgery. J Refract Surg. 2008 Feb;24(2):160-5. doi: 10.3928/1081597X-20080201-06. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of topography finding after pterygium surgery by the bare scleral technique. To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the bare scleral technique); to detect corneal curvature changes. baseline
Primary comparison of topography finding after pterygium surgery by the conjunctival auto-graft technique. To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the conjunctival auto-graft technique); to detect corneal curvature changes. baseline
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