Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery

Yonsei University

Status: Completed

Conditions: Exotropia or Intermittent Exotropia

Treatments: Device: lateral rectus recession with biodegradable collagen implant; Procedure: Lateral rectus recession without biodegradable collagen implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02699580

4-2015-0741

Details and patient eligibility

About

This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.

Enrollment: 20 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with intermittent exotropia or constant exotropia
2. Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
3. Subjects who want to do strabismus surgery

Exclusion criteria

1. Subject who had previous strabismus surgery or other ocular surgery history
2. Thyroid eye disease or other connective tissue disease
3. Significant bleeding or scleral perforation during operation
4. Subjects who need to do medial rectus resection, not lateral rectus recession
5. Subjects who had a plan to do other intra or extraocular surgery within 3 months

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Biodegradable collagen implant

Experimental group

Description:

Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.

Treatment:

Device: lateral rectus recession with biodegradable collagen implant

Without biodegradable collagen implant

Active Comparator group

Description:

Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.

Treatment:

Procedure: Lateral rectus recession without biodegradable collagen implantation