Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD

NCT06324305 | Not Yet Recruiting

• 1 other identifier: SRF drainage techniques in RRD
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications

Conditions

Rhegmatogenous Retinal Detachment

Keywords

drainage techniquies; comparison; subretinal fluid

Outcome Measures

Primary Outcomes (1)

• The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV)

  optical coherence tomography (OCT) imaging after PPV

  within 1 week and within 1 month from the PPV

Study Arms (3)

Group 1

ACTIVE COMPARATOR

drainage of sub-retinal fluid from the original (primary) break

Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid

Group 2

ACTIVE COMPARATOR

drainage of sub-retinal fluid using perfluorocarbon (PFC) and removing sub-retinal fluid through the original break or peripheral retinotomy

Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid

Group 3

ACTIVE COMPARATOR

drainage of sub-retinal fluid through formation of a posterior drainage retinotomy only.

Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid

Interventions

Pars plana vitrectomy (PPV) and drainage of subretinal fluid PROCEDURE

Drainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD)

Group 1; Group 2; Group 3

Eligibility Criteria

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

You may qualify if:

• Age: above 18 years old
• Patients with rhegmatogenous retinal detachment (RRD) where the detachment is involving the macula.
• Patients with proliferative vitreoretinopathy (PVR) no more than PVR -B.
• Patients with peripheral break.
• Duration of detachment: within one month.

You may not qualify if:

• Patients with macula on RRD.
• Patients with tractional retinal detachment.
• Patients with giant retinal tear.
• Patients with proliferative vitreoretinopathy (PVR) more than PVR -B.
• More than one month duration of detachment.
• Patients with posterior staphyloma.
• Patients with recurrent retinal detachment.
• Patients with full thickness macular hole.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• Warren A, Wang DW, Lim JI. Rhegmatogenous retinal detachment surgery: A review. Clin Exp Ophthalmol. 2023 Apr;51(3):271-279. doi: 10.1111/ceo.14205. Epub 2023 Jan 25.

  PMID: 36640144 BACKGROUND

• Fu Y, Chen S, Gu ZH, Zhang YL, Li LY, Yang N. Natural history of persistent subretinal fluid following the successful repair of rhegmatogenous retinal detachment. Int J Ophthalmol. 2020 Oct 18;13(10):1621-1628. doi: 10.18240/ijo.2020.10.17. eCollection 2020.

  PMID: 33078114 BACKGROUND

• Mimouni M, Jaouni T, Ben-Yair M, Almus S, Derman L, Ehrenberg S, Almeida D, Barak Y, Zayit-Soudry S, Averbukh E. PERSISTENT LOCULATED SUBRETINAL FLUID AFTER RHEGMATOGENOUS RETINAL DETACHMENT SURGERY. Retina. 2020 Jun;40(6):1153-1159. doi: 10.1097/IAE.0000000000002565.

  PMID: 31241497 BACKGROUND

• Chen X, Zhang Y, Yan Y, Hong L, Zhu L, Deng J, Din Q, Huang Z, Zhou H. COMPLETE SUBRETINAL FLUID DRAINAGE IS NOT NECESSARY DURING VITRECTOMY SURGERY FOR MACULA-OFF RHEGMATOGENOUS RETINAL DETACHMENT WITH PERIPHERAL BREAKS: A Prospective, Nonrandomized Comparative Interventional Study. Retina. 2017 Mar;37(3):487-493. doi: 10.1097/IAE.0000000000001180.

  PMID: 27429377 BACKGROUND

MeSH Terms

Interventions

Predictive Value of Tests

Intervention Hierarchy (Ancestors)

Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dina T Mohamed, master's

  AinShams University

  PRINCIPAL INVESTIGATOR

• Tamer F Elewa, MD

  AinShams University

  STUDY CHAIR

Central Study Contacts

Dina T Mohamed, master's

CONTACT

01067747874; dina.tarek@med.asu.edu.eg

Tamer F Elewa, MD

CONTACT

01222421432; tamerfahmy@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dina kamel

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03