Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy

NCT04410861 | Unknown

• 1 other identifier: MoorfieldsEyeAbuDhabi
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Central serous retinopathy is a disease of poorly understood etiology characterized by accumulation of subretinal fluid and leading to significant decrease in vision. Micropulse laser therapy has been successfully used in the treatment of CSR of both acute and chronic types (1). In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated fluid. The mechanism of fluid resorption is unclear. There are several treatment protocols in place (2, 3). Most commonly reported are minimal protocol and so-called panmacular protocol. However, there is no comparative study between them assessing their clinical efficacy. The purpose of this trial is to compare treatment efficacy in central serous chorioretinopathy (CSR) using two laser parameter settings. Those will include minimal and panmacular protocols. Two wavelengths will be used 577nm and 810 nm for which the rest of the parameters will be defined in order to produce sublethal photostimulation. Structural and functional outcomes will be compared before and after treatment as well as measures such as number of repeat treatments or need for rescue treatment. We aim to show which of the laser arms will lead to better clinical outcomes.

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (2)

• Change in Best-Corrected Visual Acuity (BCVA)

  BCVA will be measured using ETDRS charts and number of letters will be compared before treatment and during follow-up and at the last visit.

  6 months

• Resolution of Subretinal Fluid

  This outcome will be assessed by optical coherence tomography (OCT). Microns of central retinal thickness will be compared before treatment and during follow-up and at the last visit. The presence/absence of subretinal fluid will be recorded.

  6 months

Secondary Outcomes (2)

• Visual Field Examination

  6 months

• Need for Re-treatment

  6 months

Study Arms (2)

Minimal Micropulse Arm

ACTIVE COMPARATOR

Wavelength 810 577 Power 0.75 W 0.15 W DC 5% 5% Spot size 125um 100um Duration 0.3 sec 0.3 sec Number of spots 100-120 100-120 .

Procedure: Micropulse laser photostimulation

Panmacular Micropulse Arm

EXPERIMENTAL

Wavelength 810 577 Power 1.7 W 0.425 W DC 5% 5% Spot size 500um 500um Duration 0.3 sec 0.3 sec Number of spots 400-450 400-450

Procedure: Micropulse laser photostimulation

Interventions

Micropulse laser photostimulation PROCEDURE

In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated retinal fluid. Contact lens will be used along with topical anesthesia.Following the procedure eye will be washed with balanced salt solution.

Minimal Micropulse Arm; Panmacular Micropulse Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• CSR diagnosed \< 6 months ago Willingness to undergo micropulse laser treatment and keep follow-up visits

You may not qualify if:

• High myopia Other significant macular disease, other treatment for CSR Pregnancy

Sponsors & Collaborators

• Moorfields Eye Hospital Centre Abu Dhabi: lead
• University of Warmia and Mazury in Olsztyn: collaborator
• University of Gdansk: collaborator
• The Filatov Institute of Eye Diseases and Tissue Therapy: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Moorfields Eye Hospital Centre

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (3)

• Chhablani J, Roh YJ, Jobling AI, Fletcher EL, Lek JJ, Bansal P, Guymer R, Luttrull JK. Restorative retinal laser therapy: Present state and future directions. Surv Ophthalmol. 2018 May-Jun;63(3):307-328. doi: 10.1016/j.survophthal.2017.09.008. Epub 2017 Oct 5.

  PMID: 28987614 BACKGROUND

• Kozak I, Luttrull JK. Modern retinal laser therapy. Saudi J Ophthalmol. 2015 Apr-Jun;29(2):137-46. doi: 10.1016/j.sjopt.2014.09.001. Epub 2014 Sep 28.

  PMID: 25892934 BACKGROUND

• Wood EH, Karth PA, Sanislo SR, Moshfeghi DM, Palanker DV. NONDAMAGING RETINAL LASER THERAPY FOR TREATMENT OF CENTRAL SEROUS CHORIORETINOPATHY: What is the Evidence? Retina. 2017 Jun;37(6):1021-1033. doi: 10.1097/IAE.0000000000001386.

  PMID: 27841848 RESULT

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Central Study Contacts

Igor Kozak, M.D., PhD

CONTACT

+9710266536161; igor.kozak@moorfields.ae

Jeffrey Luttrull, M.D.

CONTACT

jkluttrull@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Vitreoretinal Surgeon/Clinical Lead

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)