Inferior Oblique Muscle Belly Transposition (IOBT) Versus Inferior Oblique Muscle Recession (IO-rec) on Versions and Vertical Alignment for Primary Position Hypertropia With Inferior Oblique Overaction
Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a multi-center, randomized double-blind controlled trial to compare the effectiveness of IOBT with IO-Rec for the treatment of hypertropia with IOOA. Specific Aim 1 (Primary): To study the suboptimal surgical rates between IOBT and IO-Rec for the treatment of hypertropia with IOOA. Specific Aim 2 (Secondary): To compare the surgical successful rate of IOBT with IO-Rec for the treatment of hypertropia with IOOA.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: f
View:
• Age ≥ 4 years at the time of surgery;
• Vertical deviation (VD) in primary position (5△ ≤ VD ≤ 10△)
• IOOA for three following situations:
⁃ IOOA +1 for the operative eye and IOOA - for the follow eye;
• Without amblyopia
Locations
Other Locations
China
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Chen Zhao
dr_zhaochen@163.com
+86-021-6437-7134
Backup
Wenqing Zhu
Time Frame
Start Date: 2022-07-01
Completion Date: 2025-06-30
Participants
Target number of participants: 190
Treatments
Experimental: IOBT group
For IOBT, the whole belly of inferior oblique muscle is anchored to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle.
Active_comparator: IO-Rec group
For IO-Rec, the insertion of inferior oblique muscle is excised and anchored to the sclera 4 mm behind and 2 mm beside the temporal insertion of the inferior rectus muscle.
Related Therapeutic Areas
Sponsors
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanxi Eye Hospital, Tianjin Eye Hospital, Kunming Aier Eye Hospital, Children's Hospital of Fudan University, Renmin Hospital of Wuhan University, Xiamen Eye Center of Xiamen University, Shandong Provincial Hospital
Leads: Eye & ENT Hospital of Fudan University