Refractive Changes Following Vitrectomy

NCT04712786 | Completed

• 1 other identifier: BursaRetinaEyeH
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed o compare the refractive changes associated with pars plana vitrectomy with or without intraocular gas tamponade in pseudophakic eyes. This retrospective study included pseudophakic patients with Nd:YAG laser posterior capsulotomy who underwent 23G PPV between February 2015 and March 2019. Group 1 consisted of patients with regmatogenous RD who underwent PPV and 12% perflouropropane (C3F8) gas tamponade whereas Group 2 consisted of patients who underwent PPV for epiretinal membrane or vitreous hemorrhage (VH). No tamponade was used in Group 2. Minimum follow-up was 12 months.

Conditions

Retinal Detachment; Refractive Errors; Vitreous Hemorrhage; Epiretinal Membrane

Keywords

Myopic shift; Gas tamponade; Pars plana vitrectomy

Outcome Measures

Primary Outcomes (1)

• The rate of spherical and cylindrical refractive changes

  Changes in spherical and cylindrical refractive error 12 months after pars plana vitrectomy

  12 months

Study Arms (1)

Group

27 patients, Group 1 consisted of patients with pseudophakic rhegmatogoneous retinal detachment who underwent pars plana vitrectomy and 12% perflouropropane (C3F8) gas tamponade and 20 patients Group 2 consisted of patients with epiretinal membrane or vitreous hemorrhage who underwent PPV without any tamponade

Other: pars plana vitrectomy

Interventions

pars plana vitrectomy OTHER

23 gauge pars plana vitrectomy was performed for retinal detachment, vitreous hemorrhage or epiretinal membrane

Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pseudophakic patients treated with neodymium:yttrium-aluminum-garnet Nd: YAG laser and subsequently underwent 23 gauge pars plana vitrectomy for vitreous hemorrhage, epiretinal membrane, or rhegmatogenous retinal detachment.

You may qualify if:

• Patients aged ≥ 18 years
• Pseudophakic patients who underwent pars plana vitrectomy

You may not qualify if:

• Patients aged 18 years \>
• Patients with a spherical refractive error \> ±6 D
• Patients with a cylindrical refractive error \> ±3 D

Sponsors & Collaborators

• Bursa Retina Eye Hospital: lead

Study Sites (1)

Retina Eye Hospital

Bursa, 16130, Turkey (Türkiye)

Location

Related Publications (2)

• Hamoudi H, Kofod M, La Cour M. Refractive change after vitrectomy for epiretinal membrane in pseudophakic eyes. Acta Ophthalmol. 2013 Aug;91(5):434-6. doi: 10.1111/j.1755-3768.2012.02574.x. Epub 2012 Sep 23.

  PMID: 22998208 BACKGROUND

• Byrne S, Ng J, Hildreth A, Danjoux JP, Steel DH. Refractive change following pseudophakic vitrectomy. BMC Ophthalmol. 2008 Oct 13;8:19. doi: 10.1186/1471-2415-8-19.

  PMID: 18851731 RESULT

MeSH Terms

Conditions

Retinal Detachment; Refractive Errors; Vitreous Hemorrhage; Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sami Yılmaz, MD

  Bursa Retina Eye Hospital

  PRINCIPAL INVESTIGATOR

• Remzi Avcı, Professor

  Bursa Retina Eye Hospital

  STUDY DIRECTOR

• Aysegul Mavi Yıldız, MD

  Bursa Retina Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, ophthalmology specialist

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 15, 2021
• Study Start: December 1, 2020
• Primary Completion: December 25, 2020
• Study Completion: December 27, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

TU (1)