Clinical Trials Logo
  1. Home
  2. High Myopia
  3. NCT03023800
  4. Details
NCT03023800 Clinical Trial

Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

High Myopia Clinical Trial

Official title:
A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03023800
Other study ID # 2013meky013(2)
Secondary ID
Status Completed
Phase N/A
First received January 16, 2017
Last updated October 12, 2017
Start date April 2015
Est. completion date October 12, 2017

Study information
Verified date October 2017
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

Description:

A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 12, 2017
Est. primary completion date January 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- axial length = 26.5 mm or refractive error (spherical equivalent) = 8.0 diopter

- macular schisis

- macular retinal detachment

- evidence of posterior staphyloma on clinical examination

Exclusion Criteria:

- severe macular scar

- macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)

- prominent vitreomacular traction

- a history of vitrectomy or macular buckle

- intraocular active hemorrhage or inflammation

- any media opacity which precluded imaging or clinical evaluation of the macula

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Macular buckling
Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.
• Vitrectomy
Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia

Locations
Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retinal re-attachment rate 3 month
Secondary Post-operative best corrected visual acuity 12 month
Secondary Post-operative macular structure on optical coherance tomography 12 month
See also
  Status Clinical Trial Phase
Completed NCT01658761 - Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes N/A
Enrolling by invitation NCT03666052 - Shanghai Child and Adolescent Large-scale Eye Study -High Myopia Registration
Completed NCT03294967 - Effect of Caffeine on Ocular Circulation in High Myopes N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A
Not yet recruiting NCT05095194 - Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT N/A
Suspended NCT02915133 - The Relationship Between Structure and Visual Function in Myopia Foveoschisis
Not yet recruiting NCT05533450 - A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens N/A
Not yet recruiting NCT05042856 - To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients N/A
Completed NCT03266354 - Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation
Recruiting NCT05201677 - Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract N/A
Completed NCT02169635 - Macular Buckle With Three-armed Silicone N/A
Recruiting NCT03533647 - Development and Pathological Changes of High Myopia Among Children and Adolescents in China
Completed NCT06204211 - Genetic Research on High Myopic Individuals in Northern China
Active, not recruiting NCT05691296 - The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin N/A
Completed NCT03202485 - Comparison Between TICL and ICL+AK for High Myopic Astigmatism N/A
Not yet recruiting NCT05768152 - Repeated Low-Level Red-Light Therapy Shortens Axial Length N/A
Completed NCT00564213 - Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds Phase 4
Active, not recruiting NCT05803174 - Screening and Identification of Biomarkers for High Myopia by a Rapid Method
Completed NCT03174639 - High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps N/A
Not yet recruiting NCT06264830 - 3D Visualization System in Highly Myopic Cataract Operation N/A