NCT00993174

Brief Summary

Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 27, 2011

Status Verified

May 1, 2010

Enrollment Period

5.1 years

First QC Date

October 9, 2009

Last Update Submit

June 24, 2011

Conditions

Esotropia

Outcome Measures

Primary Outcomes (1)

  • Amount of surgery required in mm and mm/degree of deviation angle

    Immediate

Secondary Outcomes (1)

  • Motor (deviation angle) and stereoacuity outcome

    6 months

Study Arms (2)

Topical anesthesia

EXPERIMENTAL

Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)

Procedure: Topical strabismus surgery

Sub-Tenon's anesthesia

ACTIVE COMPARATOR

Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)

Procedure: Sub-Tenon's strabismus surgery

Interventions

Topical strabismus surgeryPROCEDURE

Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure

Topical anesthesia
Sub-Tenon's strabismus surgeryPROCEDURE

Surgery is carried out after sub-Tenon's injection of xylocaine

Sub-Tenon's anesthesia

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
  • Visual acuity at least 20/40 in each eye
  • Cooperation for topical anesthesia

You may not qualify if:

  • Paretic or restrictive strabismus
  • Previous eye muscle surgery
  • Significant eye disease other than strabismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Univ Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Jaime Tejedor, MD, PhD

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

May 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2013

Last Updated

June 27, 2011

Record last verified: 2010-05

Locations

ES(1)