Aqueous Release to Treat IOP Spikes Post-cataract Surgery

July 26, 2018 updated by: Anant Sharma, Bedford Hospital NHS Trust

Efficacy and Safety of Aqueous Humour Release (Burping) Performed at the Slit-lamp to Treat Acute Intraocular Pressure (IOP) Spikes Post-cataract Surgery

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.

Study Overview

Detailed Description

At present there is no de facto standard to manage acute intraocular pressure (IOP) rise following cataract surgery. Several drugs, both topical and systemic, have been tested for their ability to blunt the acute IOP spike, nevertheless none has proven to be superior and consistently effective. Oral acetazolamide has demonstrated to help controlling IOP spikes following cataract surgery in glaucomatous eyes. However there are still constraints in its widespread use, as it may be contraindicated in patients with poor renal function, sickle cell disease and sulpha drug allergy.

As a result, many units including Moorfields Eye Hospital have used a technique called known as 'burping of the corneal wound' to release fluid from inside the anterior chamber of the eye. This makes logical sense as it reduces the pressure immediately and may remove some of the causes for raised IOP such as retained viscoelastic and inflammatory molecules from inside the eye. This technique has also been used to reduce IOP in patients already receiving pharmaceutical treatment.

The technique has been used for decades, however, there is no published evidence of a proposed technique, range of IOP decrease or frequency of complications. Thus, most surgeons in most units are cautious of 'burping the wound' as it may induce infection or other complications compromising the surgical outcome due to the sudden reduced IOP reduction. Nevertheless a similar approach, needle penetrating the eye to release aqueous and reduce IOP, is becoming more popular as the first approach to treat an acute angle closure crisis, where the presenting IOP is often very high, i.e. a much more difficult and dangerous situation than post cataract surgery.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient whose post-operative IOP was regarded to be too high for visual safety, or higher than 30mmHg, on the same day or within 1 week of the surgery

Exclusion Criteria:

  • Patients with IOP less than 30 mmHg or IOP deemed by clinician not too high to treat
  • Patients unable to cooperate
  • Patients who have undergone complicated cataract surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aqueous release (Burping) of the wound

Following uneventful cataract surgery, wound "burping" will be performed in all eligible patients who gave their informed consent. The procedure will be offered whenever the intraocular pressure (IOP) is either higher than 30 mmHg or deemed inappropriate in view of the ocular condition (e.g. glaucoma).

After 'burping' the wound, patients will have their IOP measured using Goldmann application tonometry (GAT) immediately and at 2 hours. The 'burping' procedure will be repeated until satisfactory pressure is achieved and care will be taken to avoid shallowing of the anterior chamber while fluid is released. We will assess for the presence of leaks from the wound with a Seidel test with fluorescein 5% once the IOP is satisfactory. To prevent any infection after each procedure, we will prescribe post-op drops including chloramphenicol 0.5% four times a day for 2 weeks or minimum of 3 days and these will continue as per routine. All other complications will be recorded at follow-up.

  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.
Other Names:
  • 'Burping' procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of 'burping' the wound to reduce IOP (mmHg) post-cataract surgery when measured using Goldmann application tonometry (GAT)
Time Frame: 6 months
Reduction in IOP (mmHg) post-cataract surgery after the 'burping' procedure
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of IOP decrease (mmHg)
Time Frame: 6 months
To observe and record the range of IOP decrease (mmHg) from individual 'burping' procedures
6 months
Frequency of complications post-'burping' procedure
Time Frame: 6 months
Observing the frequency of complications, including but not limited to, severe pain, worsening of vision, or infection
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anant Sharma, MBBS, FRCOphth, Bedford Hospital Moorfields Eye Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 12, 2018

Primary Completion (Anticipated)

January 12, 2019

Study Completion (Anticipated)

July 12, 2019

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRAS 240539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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