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Aqueous Release to Treat IOP Spikes Post-cataract Surgery

NCT03500809 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-07-27

No results posted yet for this study

Summary

Intraocular pressure (IOP) rise after cataract surgery is an important and common problem. Over 300,000 cataract operations are done per year in the United Kingdom alone. IOP rise can adversely affect vision and can be particularly detrimental in glaucoma patients with pre-existing visual field defects. The aim of this study is to evaluate the efficacy and safety of aqueous humor release (also known as burping of the wound), a procedure that has been used for decades to quickly reduce acute IOP spikes following cataract surgery.

Currently there is no published evidence on a standard technique to perform wound burping. Similarly there is uncertainty around the amount and duration of the IOP decrease, and the type and frequency of complications eventually associated. This will be the first research project formally evaluating this procedure. This study will also help allay issues over fluid release in high IOPs and consequences of such dramatic IOP drop which concerns ophthalmologists who do not routinely use this technique.

Conditions

  • Post-Op Complication
  • Raised Ocular Pressure

Interventions

PROCEDURE

Aqueous release of the wound

1. Anaesthetic drop (tetracaine 1%) followed by povidone iodine 5% drop is instilled. After 5 minutes, a sterile 30 gauge needle tip is pressed on the posterior lip of the one of the existing cuts (paracentesis or main wound) from cataract surgery to release the fluid and consequently the pressure. 2. This will be performed under careful monitoring to avoid any undesirable shallowing of the anterior chamber of the eye.

Sponsors & Collaborators

  • Bedford Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Anant Sharma, MBBS, FRCOphth · Bedford Hospital Moorfields Eye Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-12
Primary Completion
2019-01-12
Completion
2019-07-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03500809 on ClinicalTrials.gov