Post-Op ComplicationNCT03500809
Aqueous Release to Treat IOP Spikes Post-cataract Surgery
A study testing Aqueous release of the wound in people with Post-Op Complication and Raised Ocular Pressure, run by Bedford Hospital NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-Op Complication, Raised Ocular Pressure
- What is being tested?
- Aqueous release of the wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2018to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Op Complication, Raised Ocular Pressure
- Being tested
- Aqueous release of the wound
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous release of the woundProcedure or surgery
Also called 'Burping' procedure
- 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.
- This will be performed under careful monitoring to avoid any undesirable shallowing of the anterior chamber of the eye.
| Study group | Role | What they receive |
|---|---|---|
| Aqueous release (Burping) of the wound | Experimental | 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. Receives: Procedure: Aqueous release of the wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 'burping' the wound to reduce IOP (mmHg) post-cataract surgery when measured using Goldmann application tonometry (GAT)
Reduction in IOP (mmHg) post-cataract surgery after the 'burping' procedure
Measured: 6 months
Secondary outcomes (2)
Range of IOP decrease (mmHg)
To observe and record the range of IOP decrease (mmHg) from individual 'burping' procedures
Measured: 6 months
Frequency of complications post-'burping' procedure
Observing the frequency of complications, including but not limited to, severe pain, worsening of vision, or infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start12 Aug 2018 (estimated)
- Primary completion12 Jan 2019 (estimated)
- Study completion12 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedford Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anant Sharma, Bedford Hospital NHS Trust
- Investigators
- Anant Sharma, MBBS, FRCOphth, Principal investigator, Bedford Hospital Moorfields Eye Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500809
- Sponsor's protocol ID
- IRAS 240539
- Status last verified
- Jul 2018
- First submitted
- 6 Apr 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.
PubMed 25679413Kim JY, Jo MW, Brauner SC, Ferrufino-Ponce Z, Ali R, Cremers SL, Henderson BA. Increased intraocular pressure on the first postoperative day following resident-performed cataract surgery. Eye (Lond). 2011 Jul;25(7):929-36. doi: 10.1038/eye.2011.93. Epub 2011 Apr 29.
PubMed 21527959Tranos P, Bhar G, Little B. Postoperative intraocular pressure spikes: the need to treat. Eye (Lond). 2004 Jul;18(7):673-9. doi: 10.1038/sj.eye.6701319.
PubMed 15002028Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JK, Miller JP, Parrish RK, Wilson MR; Ocular Hypertension Treatment Study Group. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010 Mar;128(3):276-87. doi: 10.1001/archophthalmol.2010.20.
PubMed 20212196Hayashi K, Yoshida M, Manabe SI, Yoshimura K. Prophylactic Effect of Oral Acetazolamide against Intraocular Pressure Elevation after Cataract Surgery in Eyes with Glaucoma. Ophthalmology. 2017 May;124(5):701-708. doi: 10.1016/j.ophtha.2016.12.027. Epub 2017 Jan 19.
PubMed 28110949Wang Q, Harasymowycz P. Short-Term Intraocular Pressure Elevations after Combined Phacoemulsification and Implantation of Two Trabecular Micro-Bypass Stents: Prednisolone versus Loteprednol. J Ophthalmol. 2015;2015:341450. doi: 10.1155/2015/341450. Epub 2015 Jul 21.
PubMed 26266045Cioboata M, Anghelie A, Chiotan C, Liora R, Serban R, Cornacel C. Benefits of anterior chamber paracentesis in the management of glaucomatous emergencies. J Med Life. 2014;7 Spec No. 2(Spec Iss 2):5-6.
PubMed 25870663
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aqueous Humour Release (Burping) Performed at the Slit-lamp to Treat Acute Intraocular Pressure (IOP) Spikes Post-cataract Surgery
- ClinicalTrials.gov ID
- NCT03500809
- Acronym / sponsor ID
- IRAS 240539
- Conditions
- Post-Op Complication, Raised Ocular Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bedford Hospital NHS TrustUniversity, hospital or other
- Study start
- 12 Aug 2018 (estimated)
- Primary completion
- 12 Jan 2019 (estimated)
- Study completion
- 12 Jul 2019 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aqueous release (Burping) of the wound | Experimental | Procedure: Aqueous release of the woundFollowing 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqueous release of the woundAlso: 'Burping' procedure1. 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. | Procedure or surgery | Aqueous release (Burping) of the wound |
Primary outcome
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
2 secondary outcomes
Range of IOP decrease (mmHg)
Time frame: 6 months
Frequency of complications post-'burping' procedure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Background: PubMed 25679413Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.
- Background: PubMed 21527959Kim JY, Jo MW, Brauner SC, Ferrufino-Ponce Z, Ali R, Cremers SL, Henderson BA. Increased intraocular pressure on the first postoperative day following resident-performed cataract surgery. Eye (Lond). 2011 Jul;25(7):929-36. doi: 10.1038/eye.2011.93. Epub 2011 Apr 29.
- Background: PubMed 15002028Tranos P, Bhar G, Little B. Postoperative intraocular pressure spikes: the need to treat. Eye (Lond). 2004 Jul;18(7):673-9. doi: 10.1038/sj.eye.6701319.
- Background: PubMed 20212196Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JK, Miller JP, Parrish RK, Wilson MR; Ocular Hypertension Treatment Study Group. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010 Mar;128(3):276-87. doi: 10.1001/archophthalmol.2010.20.
- Background: PubMed 28110949Hayashi K, Yoshida M, Manabe SI, Yoshimura K. Prophylactic Effect of Oral Acetazolamide against Intraocular Pressure Elevation after Cataract Surgery in Eyes with Glaucoma. Ophthalmology. 2017 May;124(5):701-708. doi: 10.1016/j.ophtha.2016.12.027. Epub 2017 Jan 19.
- Background: PubMed 26266045Wang Q, Harasymowycz P. Short-Term Intraocular Pressure Elevations after Combined Phacoemulsification and Implantation of Two Trabecular Micro-Bypass Stents: Prednisolone versus Loteprednol. J Ophthalmol. 2015;2015:341450. doi: 10.1155/2015/341450. Epub 2015 Jul 21.
- Background: PubMed 25870663Cioboata M, Anghelie A, Chiotan C, Liora R, Serban R, Cornacel C. Benefits of anterior chamber paracentesis in the management of glaucomatous emergencies. J Med Life. 2014;7 Spec No. 2(Spec Iss 2):5-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anant Sharma, MBBS, FRCOphth principal investigator
Bedford Hospital Moorfields Eye Unit
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous release of the wound in people with Post-Op Complication and Raised Ocular Pressure, run by Bedford Hospital NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anant Sharma, MBBS, FRCOphth (01234355122 ext. 01234, anant.sharma@bedfordhospital.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of 'burping' the wound to reduce IOP (mmHg) post-cataract surgery when measured using Goldmann application tonometry (GAT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500809, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.