Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

Nanophthalmos Clinical Trial

Official title:

Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03748732
• Other study ID #: RaficHaririUHAMM
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2018
• Source: Rafic Hariri University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.

Design: Prospective interventional case series.

Methods:

• Setting: Institutional.

• Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.

• Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.

• Main Outcome Measure: Resolution or prevention of uveal effusion.

Description:

Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

Related Conditions & MeSH terms

• Microphthalmos
• Nanophthalmos

Intervention

Procedure:
• sclerectomy
scleral flap

Locations

Country	Name	City	State
Lebanon	Rafic Hariri University Hospital	Beirut	South Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Rafic Hariri University Hospital

Country where clinical trial is conducted

Lebanon, 

References & Publications (1)

Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resolution of uveal effusion	disappearence of uveal effusion by OCT	1 month