Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments

Retinal Detachment Clinical Trial

Official title:

Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292572
• Other study ID #: 2024PI029
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Ida Gordon
• Phone: +33622820203
• Email: gordon.ida14[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments

Description:

Bilateral retinal detachment is a rare but sight-threatening disease, that can cause blindness and poor quality of life.

It has been proved that patients who suffer from RD in one eye have a considerably increased risk to subsequently develop an RD in the fellow eye.

It can be expected that patients who experienced a RD in one eye, tend to present sooner when experiencing a RD in the fellow eye, and thus have a greater visual and/or anatomical prognosis.

In this study, we aim to describe characteristics of bilateral RD and compare the initial and subsequent eye in terms of clinical preoperative features, surgical management, and anatomical and visual results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients that underwent retinal detachment repair surgery for bilateral sequential retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center (via pars plana vitrectomy or scleral buckling) and with a minimum of 6 month of post-operative follow-up after the last surgery.

Exclusion Criteria:

• Patients that underwent surgery at another facility

• Patients with a history of previous vitrectomy or

• Patients with a history of trauma from a penetrating injury or ruptured globe, retinal neovascular condition, hereditary vitreo-retinopathy

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Procedure:
• Retinal Detachment Surgery
Retinal Detachment Surgery that consists in either Pars Plana Vitrectomy or Scleral Buckling or a combination of both techniques, and with or without use of intraocular tamponade

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre les nancy	Meurthe-et-Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Mastropasqua L, Carpineto P, Ciancaglini M, Falconio G, Gallenga PE. Treatment of retinal tears and lattice degenerations in fellow eyes in high risk patients suffering retinal detachment: a prospective study. Br J Ophthalmol. 1999 Sep;83(9):1046-9. doi: 10.1136/bjo.83.9.1046. — View Citation

Mitry D, Singh J, Yorston D, Siddiqui MA, Murphy AL, Wright AF, Fleck BW, Campbell H, Charteris DG. The fellow eye in retinal detachment: findings from the Scottish Retinal Detachment Study. Br J Ophthalmol. 2012 Jan;96(1):110-3. doi: 10.1136/bjo.2010.194852. Epub 2011 Mar 3. — View Citation

Radeck V, Schindler F, Helbig H, Gamulescu MA, Cvetkov Y, Barth T, Maerker D. Characteristics of Bilateral Retinal Detachment. Ophthalmologica. 2023;246(2):99-106. doi: 10.1159/000527625. Epub 2022 Oct 25. — View Citation

Walia HS, Shah GK, Blinder KJ. Characteristics and outcomes of sequential rhegmatogenous retinal detachments. Ophthalmic Surg Lasers Imaging Retina. 2015 Apr;46(4):445-9. doi: 10.3928/23258160-20150422-07. — View Citation

Xu D, Belin PJ, Staropoli PC, Yannuzzi NA, Vangipuram G, Chiang A, Shah GK, Townsend JH, Ryan EH, Klufas MA. Clinical Outcomes in Sequential, Bilateral Rhegmatogenous Retinal Detachment: A Multicenter, Paired-Eye Analysis. Ophthalmol Retina. 2021 Aug;5(8):797-804. doi: 10.1016/j.oret.2020.11.002. Epub 2020 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of surgical success	Rate of succesful surgical repair of RD within the follow-up period	6 month after surgery
Secondary	Visual Acuity	LogMAR Visual acuity measured at the follow-up visit	6 month after surgery