## Protocol Section
### Identification Module
**NCT ID:** NCT00370279

**Brief Title:** Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial

#### Organization Study ID Info
**ID:** 8405
#### Organization
**Class:** OTHER
**Full Name:** Shahid Beheshti University of Medical Sciences
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2008-06-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-06-25

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2005-09

**Status Verified Date:** 2008-06

#### Study First Post Date
**Date:** 2006-08-31
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-30
**Study First Submit QC Date:** 2006-08-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shahid Beheshti University of Medical Sciences

### Description Module

**Brief Summary:** To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment

### Conditions Module

**Conditions:**

- Pseudophakic Retinal Detachment

- Aphakic Retinal Detachment

**Keywords:**

- Pseudophakic retinal detachment,

- Aphakic retinal detachment,

- Scleral buckling,

- Primary vitrectomy,

- Proliferative vitreoretinopathy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** scleral buckling

**Intervention Names:**

- Procedure: scleral buckling, primary vitrectomy

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Primary vitrectomy without encircling band

**Intervention Names:**

- Procedure: scleral buckling, primary vitrectomy

**Label:** 2

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Primary vitrectomy with encircling band

**Intervention Names:**

- Procedure: scleral buckling, primary vitrectomy

**Label:** 3

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Description:** Triamcinolone assisted vitrectomy

**Intervention Names:**

- Procedure: scleral buckling, primary vitrectomy

**Label:** 4

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

- 3

- 4

**Description:** Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy

**Name:** scleral buckling, primary vitrectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Retinal reattachment rate

**Measure:** Visual acuity

#### Secondary Outcomes

**Measure:** Proliferative vitreoretinopathy

**Measure:** Macular Pucker

**Measure:** Anisometropia

**Measure:** Choroidal detachment

**Measure:** Reoperation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Cases of pseudophakic and aphakic retinal detachment with PVR grade A or B

Exclusion Criteria:

* PVR grade C
* History of surgery for RD
* Signs of diabetic retinopathy, AMD, glaucoma and macular hole
* History of ocular trauma
* Giant retinal tear

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hahmadieh@hotmail.com

**Name:** Hamid Ahmadieh, MD

**Phone:** +98 21 22585952

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tehran

**Contacts:**

***Contact 1:***

- **Email:** hahmadieh@hotmail.com

- **Name:** Hamid Ahmadieh, MD

- **Phone:** +98 21 22585952

- **Role:** CONTACT

**Country:** Iran, Islamic Republic of

**Facility:** Hamid Ahmadieh, MD

**Status:** RECRUITING

**Zip:** 16666

#### Overall Officials

**Official 1:**

**Affiliation:** Ophthalmic Research Center of Shaheed Beheshti Medical University

**Name:** Hamid Ahmadieh, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000012164

- Term: Retinal Diseases

- 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: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14998

- Name: Retinal Detachment

- Relevance: HIGH

- As Found: Retinal Detachment

- ID: M20719

- Name: Vitreoretinopathy, Proliferative

- Relevance: LOW

- As Found: Unknown

- ID: M6515

- Name: Conversion Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M7394

- Name: Dissociative Disorders

- Relevance: HIGH

- As Found: Detachment

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5871

- Name: Vitreoretinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: T1568

- Name: Conversion Disorder

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012163

- Term: Retinal Detachment

- ID: D000004213

- Term: Dissociative Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16975

- Name: Triamcinolone Acetonide

- Relevance: LOW

- As Found: Unknown

- ID: M16974

- Name: Triamcinolone

- Relevance: LOW

- As Found: Unknown

- ID: M237966

- Name: Triamcinolone hexacetonide

- Relevance: LOW

- As Found: Unknown

- ID: M209573

- Name: Triamcinolone diacetate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
