NCT06524661

Brief Summary

To evaluate changes in ACA induced by pars plana vitrectomy with SO 1000cs injection in vitreo-retinal surgery in phakic eyes using AS-OCT and changes in the IOP preoperatively, post-operatively and post-silicone oil evacuation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 19, 2024

Last Update Submit

July 26, 2024

Conditions

Keywords

ASOCTGlaucomaSiliconevitrectomyangle

Outcome Measures

Primary Outcomes (1)

  • Assessement of the changes in anterior chamber angle after vitrectomy with silicone oil injection

    Evaluation of changes in the anterior chamber angle parameters after vitrectomy with silicone oil 1000cs injection. The measures include AOD 500, TISA 500, ACA and CCT The measuring tool is AS-OCT (anterior segment optical coherent topography)

    postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )

Study Arms (1)

Patients with RRD who underwent pars plana vitrectomy with

AS-oct measuring the anterior chamber angle and corneal changes after pars plana vitrectomy with silicone oil 1000cs injection

Device: AS-OCT after vitrectomy

Interventions

AS-OCT is a light based imaging technique of the anterior segment of the eye in this study it is used to measure the anterior chamber angle changes after pars plana vitrectomy.

Also known as: vitrectomy, silicone oil 1000cs, silicone oil evacuation
Patients with RRD who underwent pars plana vitrectomy with

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are phakic with rhegmatogenous retinal detachment

You may qualify if:

  • Patients with rhegmatogenous retinal detachment who are going to undergo vitreoretinal surgery with silicone oil 1000cs injection as tamponade

You may not qualify if:

  • Patients with history of intraocular surgery, laser therapy or intravitreal injection.
  • Patients with significant corneal opacity.
  • Patients with ocular diseases as retinal vein occlusion, uveitis and proliferative diabetic retinopathy.
  • Patients with preexisting glaucoma or family history of glaucoma.
  • Patients with nystagmus.
  • Patient with tractional retinal detachment, exudative retinal detachment or intraocular foreign body.
  • Patients with anterior chamber abnormalities including posterior synechia, peripheral anterior synechia, hyphaema and iris abnormalities.
  • Patients with severe proliferative vitreoretinopathy grade C or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine ,Minia university

Minya, 61519, Egypt

Location

Related Publications (1)

  • Calik B, Ozturk M, Serdarogullari H, Elcioglu M. Evaluation of anterior segment parameters using pentacam in silicone oil-injected patients after pars plana vitrectomy. Indian J Ophthalmol. 2013 Nov;61(11):621-5. doi: 10.4103/0301-4738.123137.

    PMID: 24343592BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohab Mohamed Khairy Talaat

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 29, 2024

Study Start

April 15, 2023

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations