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Aqueous Release to Treat IOP Spikes Post-cataract Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03500809
Enrollment
20
Registered
2018-04-18
Start date
2018-08-12
Completion date
2019-07-12
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Op Complication, Raised Ocular Pressure

Brief 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.

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.

Interventions

PROCEDUREAqueous 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

Bedford Hospital NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of 'burping' the wound to reduce IOP (mmHg) post-cataract surgery when measured using Goldmann application tonometry (GAT)6 monthsReduction in IOP (mmHg) post-cataract surgery after the 'burping' procedure

Secondary

MeasureTime frameDescription
Range of IOP decrease (mmHg)6 monthsTo observe and record the range of IOP decrease (mmHg) from individual 'burping' procedures
Frequency of complications post-'burping' procedure6 monthsObserving the frequency of complications, including but not limited to, severe pain, worsening of vision, or infection

Contacts

Primary ContactAnant Sharma, MBBS, FRCOphth
anant.sharma@bedfordhospital.nhs.uk01234355122
Backup ContactRynda Nitiahpapand, MBBS
rynda.nitiahpapand@bedfordhospital.nhs.uk01234355122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026