Management of Cystoid Macular Edema Secondary to Retinitis Pigmentosa Via Subliminal Micropulse Yellow Laser

NCT04234438 | Completed DMC

• 1 other identifier: 20-1249-17
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose: To investigate the effects of subliminal micropulse yellow laser application on central macular thickness and best corrected visual acuity in cystoid macular edema secondary to retinitis pigmentosa patients.

Conditions

Retinitis Pigmentosa; Cystoid Macular Edema

Keywords

Retinitis pigmentosa; Cystoid macular edema; Intraretinal cysts; Subliminal micropulse laser

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

  It is obtained by measuring the distance between the internal limiting membrane and the bruch membrane in the center of fovea by OCT.

  Change from baseline central macular thickness at 12 months

Study Arms (2)

Before application

ACTIVE COMPARATOR

32 eyes of 29 patients who had cystoid macular edema secondary to retinitis pigmentosa Before subliminal micropulse laser application

Device: SL-MPL treatment protocol was performed with a 577 nm yellow laser (EasyRet, Quantel Medical, Cedex, France)

After application

ACTIVE COMPARATOR

32 eyes of 29 patients who had cystoid macular edema secondary to retinitis pigmentosa After 12 months subliminal micropulse laser application

Device: SL-MPL treatment protocol was performed with a 577 nm yellow laser (EasyRet, Quantel Medical, Cedex, France)

Interventions

SL-MPL treatment protocol was performed with a 577 nm yellow laser (EasyRet, Quantel Medical, Cedex, France) DEVICE

Macular laser treatment was applied after pupil dilation and topical anesthesia. Laser application was performed with a Mainster Standard contact laser lens (Volk Optical, Mentor, OH, USA). To determine the appropriate personalized calibration value, single-spot test shot was applied under the green filter to a non-edematous area of the macula outside the temporal vascular arcade. The laser power was gradually increased until it formed a barely visible laser spot. The power of the micropulse pattern laser was set at 50% of the power needed to form a barely visible laser spot. Laser parameters used were 200 ms duration, 160 µm spot diameter, low operating cycle (5%), and zero spacing with 5x5 pattern shape. SL-MPL was applied to the areas where edema was detected in OCT and examination.

After application; Before application

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of any phenotypic variation of RP
• Presence of separeted intraretinal cysts
• Central macular thickness ≥ 500 µm
• Unresponsive to systemic or topical carbonic anhydrase inhibitors
• No interventional treatment for macular edema in the last 3 months

You may not qualify if:

• Patients with signs of inflammation, such as cells in the vitreous, intraretinal white dots, septa-free edema
• Patients responding to systemic or topical carbonic anhydrase inhibitors
• Any interventional treatment has been applied for macular edema in the last 3 months
• The presence of other causes that may lead to CME such as epiretinal membrane, vitreous traction, diabetes or uveitis.

Sponsors & Collaborators

• Ankara Universitesi Teknokent: lead

Study Sites (2)

Ankara University Biotechnology Institute

Ankara, Türkiye, 06312, Turkey (Türkiye)

Location

Umut Arslan

Ankara, Türkiye, 06312, Turkey (Türkiye)

Location

Related Publications (4)

• Bakthavatchalam M, Lai FHP, Rong SS, Ng DS, Brelen ME. Treatment of cystoid macular edema secondary to retinitis pigmentosa: a systematic review. Surv Ophthalmol. 2018 May-Jun;63(3):329-339. doi: 10.1016/j.survophthal.2017.09.009. Epub 2017 Oct 5.

  PMID: 28987613 RESULT

• Scholz P, Altay L, Fauser S. A Review of Subthreshold Micropulse Laser for Treatment of Macular Disorders. Adv Ther. 2017 Jul;34(7):1528-1555. doi: 10.1007/s12325-017-0559-y. Epub 2017 May 24.

  PMID: 28540655 RESULT

• Luttrull JK. Improved retinal and visual function following panmacular subthreshold diode micropulse laser for retinitis pigmentosa. Eye (Lond). 2018 Jun;32(6):1099-1110. doi: 10.1038/s41433-018-0017-3. Epub 2018 Feb 16.

  PMID: 29449615 RESULT

• Arslan U. Management of cystoid macular edema secondary to retinitis pigmentosa via subliminal micropulse yellow laser. Lasers Med Sci. 2021 Mar;36(2):317-323. doi: 10.1007/s10103-020-03031-0. Epub 2020 May 4.

  PMID: 32363437 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa; Macular Edema

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Macular Degeneration

Study Officials

• Umut Arslan, MD

  Ankara Universitesi Teknokent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, MD

Model Details: Prospective open-label clinical trial, included 32 eyes of 29 patients who had cystoid macular edema secondary to retinitis pigmentosa. Patients were treated by subliminal micropulse yellow laser for one session. Central macular thickness and best corrected visual acuity changes were investigated just before the treatment and 1 year later after the one session of the treatment.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: January 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)