Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury

NCT05771467 | Completed Results

• 1 other identifier: AKDENIZ-GOZ-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.

Conditions

Eye Injury Trauma

Keywords

Eye Injury Trauma; Open Globe Injury; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (11)

• Corneal Thickness

  Corneal thickness in mikrometer value

  10 minutes

• Anterior Chamber Volume

  Anterior chamber volume in mm3

  10 minutes

• Anterior Chamber Depth

  Anterior chamber depth in mm

  10 minutes

• Anterior Chamber Angle

  Anterior chamber angle in degree

  10 minutes

• Lens Power

  in diopters

  10 minutes

• Steep Keratometry

  in Diopters measured with pentacam

  10 minutes

• Tonometry

  Intraocular pressure measurement in mmHg

  10 minutes

• Axial Length

  Axial length in mm

  10 minutes

• Optic Nerve Head Vessel Density

  Optic nerve head vessel density assessed with optical coherence tomography angiography

  10 minutes

• Choriocapillaris Flow Area

  Choriocapillaris flow area assessed with optical coherence tomography angiography

  10 minutes

• Subfoveal Central Macular Thickness

  Subfoveal central macular thickness assessed with optical coherence tomography

  10 minutes

Study Arms (2)

Trauma Group

Non-trauma eye after open globe injury determine retinal microvascular changes

Diagnostic Test: Comprehensive Ophthalmologic Examination

Control Group

Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers

Diagnostic Test: Comprehensive Ophthalmologic Examination

Interventions

Comprehensive Ophthalmologic Examination DIAGNOSTIC_TEST

Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)

Also known as: Optical Coherence Tomography Angiography (OCTA), Biometry, Auto refractometry, Non contact tonometry

Control Group; Trauma Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Middle age, predominantly male

You may qualify if:

• Be over 18 years old
• Unilateral eye injury

You may not qualify if:

• Be under the age of 18
• Usage of systemic drugs or topical ocular drops
• Bilateral eye injury
• Having systemic disease, having ocular pathology that may decrease visual acuity

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (2)

Aslı Çentinkaya Yaprak

Antalya, 070059, Turkey (Türkiye)

Location

Yusuf Samet Atlıhan

Antalya, 07070, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Dr. Aslı Cetinkaya Yaprak
• Organization: AkdenizU

ysf20smt@gmail.com

+0905069228431

Study Officials

• Yusuf Samet Atlıhan, MD, 1

  Akdeniz University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: March 2, 2024
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)