Clinical Trials Logo
  1. Home
  2. High Myopia
  3. NCT03381079
  4. Details
NCT03381079 Clinical Trial

Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia

High Myopia Clinical Trial

Official title:
Posterior Scleral Reinforcement for Adults With High Myopia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03381079
Other study ID # TRECKY2017-049
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received December 12, 2017
Last updated December 20, 2017
Start date April 1, 2018
Est. completion date December 31, 2020

Study information
Verified date December 2017
Source Beijing Tongren Hospital
Contact Shi-Ming Li, PhD
Phone +86-10-58269920
Email lishiming81@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Cycloplegic spherical equivalent less than -6.0 D

- Myopia progression greater than 1.0 D per year

- Normal IOP, no strabismus or any other ocular pathological changes

- no any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria:

- Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)

- Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Posterior scleral reinforcement
Posterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tongren Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Cycloplegic autorefraction Level of myopia and myopia progression as assessed by autorefraction 2 years
Primary Axial length Longth of the eyeball as assessed by IOL Master or Lenstar 2 years
Secondary Number of participants with treatment-related adverse events Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc. 2 years
Secondary Visual acuity An index for visual function measured by visual acuity chart 2 years
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