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Efficacy and Safety of Posterior Scleral Reinforcement Combined with ICL Implantation for the Treatment of High Myopia Combined with Anisometropia in Children: A Prospective Self-Controlled Study

Efficacy and Safety of Posterior Scleral Reinforcement Combined with ICL Implantation for the Treatment of High Myopia Combined with Anisometropia in Children: A Prospective Self-Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124684
Enrollment
Unknown
Registered
2026-05-15
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Treatment group:Posterior Scleral Reinforcement Combined with ICL Implantation

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Aged 5 to 14 years, within the plastic period of visual development; 2.Unilateral or bilateral high myopia (spherical equivalent ranging from -20.00D to -6.00D after cycloplegic refraction), with axial length (AL) >= 25.0 mm; 3.Anterior chamber depth >=2.8 mm, corneal endothelial cell density >= 2000 cells/mm^2; 4.Preoperative intraocular pressure =2.5D; 6.Poor corrected visual acuity in one or both eyes, meeting the diagnostic criteria for amblyopia (BCVA below the minimum normal visual acuity for the corresponding age, or interocular visual acuity difference >= 2 lines); 7.Scheduled to undergo PSR combined with ICL implantation, with informed consent signed by parents or legal guardians; 8.Able to attend preoperative and postoperative follow-up visits and cooperate with all examinations and visual function assessments.

Exclusion criteria

Exclusion criteria: 1.Preoperative glaucoma or elevated intraocular pressure exceeding 21 mmHg due to any cause; 2.Any ocular conditions contraindicating surgery, including corneal endothelial dystrophy, active ocular diseases and infections, cataract, etc. 3.Any systemic diseases affecting the eyes and precluding surgery, such as thyroid-associated ophthalmopathy, diabetic retinopathy, systemic connective tissue diseases or autoimmune diseases including multiple sclerosis, systemic lupus erythematosus, etc.

Design outcomes

Primary

MeasureTime frame
Best Corrected Visual Acuity;Axial lengths;Diopter;

Secondary

MeasureTime frame
Intraocular pressure;Spherical equivalent;

Countries

China

Contacts

Public ContactZhou Jibo

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

zhoujibo1000@aliyun.com+86 21 23271699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026