## Protocol Section
### Identification Module
**NCT ID:** NCT06434155

**Acronym:** OCT

**Brief Title:** Social History and Glaucoma Progression

**Official Title:** Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma

#### Organization Study ID Info
**ID:** 17200545
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2022-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Khaled Abdelazeem

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments

**Detailed Description:** Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH.

When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.

### Conditions Module

**Conditions:**

- Glaucoma Open-Angle

**Keywords:**

- Glaucoma

- OCT

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1584

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 1. Patients older than 18 years of age with primary open-angle glaucoma (POAG)
2. POAG diagnosed on the basis of IOP measurements more than 21 mmHg, Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.
3. Eyes with baseline macular and ONH OCT images and ONH photographs of adequate quality and r performed within 6 months of each other were selected

**Label:** Primary Open Angle Glaucoma

### Outcomes Module

#### Primary Outcomes

**Description:** RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT

**Measure:** OCT structural parameters

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* IOP measurements more than 21 mmHg
* Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
* Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
* Eyes with baseline macular and ONH OCT images and ONH photograps

Exclusion Criteria:

* Participants with significant retinal disease.
* non-glaucomatous optic neuropathy.
* anomalous discs
* any retinal pathology.
* history of cataract or glaucoma surgery will not be exclusion criteria.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients older than 18 years of age with primary open-angle glaucoma (OAG)

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Assiut

**Country:** Egypt

**Facility:** Faculty of Medicine

**Zip:** 71515

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009798

- Term: Ocular Hypertension

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9013

- Name: Glaucoma

- Relevance: HIGH

- As Found: Glaucoma

- ID: M9014

- Name: Glaucoma, Open-Angle

- Relevance: HIGH

- As Found: Glaucoma Open-Angle

- ID: M3774

- Name: Alcohol Drinking

- Relevance: LOW

- As Found: Unknown

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M12731

- Name: Ocular Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005901

- Term: Glaucoma

- ID: D000005902

- Term: Glaucoma, Open-Angle

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
