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Completed

NCT Number: NCT06524661

Anterior Segment Changes After Pars Plana Vitrectomy With SO Using AS-OCT

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.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine ,Minia university

Minya, 61519, Egypt

About this study

Abstract Introduction Ocular hypertension and secondary glaucoma are relatively common and serious complications in silicone filled eyes which may end in blindness. Reports have described the percentage of incidence to be within 3 - 30 % of silicon filled eye which are complicated with secondary glaucoma. [1] Aim of study Evaluation of changes in anterior chamber angle and intra-ocular pressure (IOP) in patients with rhegmatogenous retinal detachment (RRD) who underwent pars plana vitrectomy (PPV) with silicone oil (SO) 1000cs tamponade and after silicone oil evacuation.

Population The study was a prospective interventional study. The study included 30 eyes from 30 patients with rhegmatogenous retinal detachment (RRD) who are going to undergo PPV with SO injection. The study was conducted at Ophthalmology department, Minia University Hospital in Egypt between April 2023 and April 2024.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

AS-OCT after vitrectomy

Device

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.

Other names: vitrectomy, silicone oil 1000cs, silicone oil evacuation

Primary outcomes

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

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

    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)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Anterior Segment Changes After Pars Plana Vitrectomy With Silicone Oil Tamponade And After Silicone Oil Evacuation Using AS-OCT.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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