Cystoid Macular Edema, PostoperativePhase 4NCT02646072
Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients
A Phase 4 study testing Ketorolac tromethamine ophthalmic solution 0.45% in people with Cystoid Macular Edema, Postoperative and Diabetes Mellitus, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystoid Macular Edema, Postoperative, Diabetes Mellitus
- What is being tested?
- Ketorolac tromethamine ophthalmic solution 0.45%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2014to Jun 2015
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patient group
- Type 2 diabetes mellitus with no diabetic retinopathy
- If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
- Listed for phacoemulsification cataract surgery
- Non diabetic patient group
- No history of diabetes
- If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
- Listed for phacoemulsification cataract surgery
Who cannot join
- Smoker
- Presence of immune disease, local or systemic inflammation
- Presence of retinal diseases, glaucoma
- Previous surgical procedure on the eye
- Intra-operative complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery
The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.
Read the detailed description
To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.
To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.
- Being tested
- Ketorolac tromethamine ophthalmic solution 0.45%
- Keywords
- diabetes mellitus, aqueous humor, inflammatory cytokines, cystoid macular edema, postoperative, nonsteroidal anti-inflammatory drugs
- Medical subject headings
- Macular Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac tromethamine ophthalmic solution 0.45%Drug
Also called Acuvail
Indicated for the treatment of pain and inflammation following cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus patients | Active comparator | Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery Receives: Drug: Ketorolac tromethamine ophthalmic solution 0.45% |
| Diabetes mellitus control patients | No intervention | Topical refresh plus four times a day for 3 days prior to cataract surgery |
| Non diabetic patients | Active comparator | Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery Receives: Drug: Ketorolac tromethamine ophthalmic solution 0.45% |
| Non diabetic control patients | No intervention | Topical refresh plus four times a day for 3 days prior to cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
Aqueous samples were analyzed at the same after complete samples collection.
Measured: 9 months
Secondary outcomes (1)
Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cystoid Macular Edema, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Yin Peng, MD, University of Malaya
- Investigators
- Yin Peng Lai, MOphthal, Principal investigator, University of MalayaMohammadreza Peyman, Mophthal, Study chair, University of MalayaTajunisah Iqbal, FRCS Ophth, Study director, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646072
- Sponsor's protocol ID
- 20148-494
- Status last verified
- Jan 2016
- First submitted
- 12 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cheung CM, Vania M, Ang M, Chee SP, Li J. Comparison of aqueous humor cytokine and chemokine levels in diabetic patients with and without retinopathy. Mol Vis. 2012;18:830-7. Epub 2012 Apr 4.
PubMed 22511846Dong N, Xu B, Wang B, Chu L. Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis. 2013 Aug 4;19:1734-46. Print 2013.
PubMed 23922491Chu L, Wang B, Xu B, Dong N. Aqueous cytokines as predictors of macular edema in non-diabetic patients following uncomplicated phacoemulsification cataract surgery. Mol Vis. 2013 Nov 24;19:2418-25. eCollection 2013.
PubMed 24319335Yilmaz T, Cordero-Coma M, Gallagher MJ. Ketorolac therapy for the prevention of acute pseudophakic cystoid macular edema: a systematic review. Eye (Lond). 2012 Feb;26(2):252-8. doi: 10.1038/eye.2011.296. Epub 2011 Nov 18.
PubMed 22094296Schoenberger SD, Kim SJ, Sheng J, Calcutt MW. Reduction of vitreous prostaglandin E2 levels after topical administration of ketorolac 0.45%. JAMA Ophthalmol. 2014 Feb;132(2):150-4. doi: 10.1001/jamaophthalmol.2013.5692.
PubMed 24264034Schoenberger SD, Kim SJ, Shah R, Sheng J, Cherney E. Reduction of interleukin 8 and platelet-derived growth factor levels by topical ketorolac, 0.45%, in patients with diabetic retinopathy. JAMA Ophthalmol. 2014 Jan;132(1):32-7. doi: 10.1001/jamaophthalmol.2013.6203.
PubMed 24336915Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550-8. doi: 10.1016/j.jcrs.2007.05.013.
PubMed 17720069Almeida DR, Johnson D, Hollands H, Smallman D, Baxter S, Eng KT, Kratky V, ten Hove MW, Sharma S, El-Defrawy S. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg. 2008 Jan;34(1):64-9. doi: 10.1016/j.jcrs.2007.08.034.
PubMed 18165083Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
PubMed 18599019Bucci FA Jr, Waterbury LD. A randomized comparison of to-aqueous penetration of ketorolac 0.45%, bromfenac 0.09% and nepafenac 0.1% in cataract patients undergoing phacoemulsification. Curr Med Res Opin. 2011 Dec;27(12):2235-9. doi: 10.1185/03007995.2011.626018. Epub 2011 Oct 12.
PubMed 21992076Heier JS, Awh CC, Busbee BG, Waterbury LD, Daniel P, Stoller GL, Cleary TS. Vitreous nonsteroidal antiinflammatory drug concentrations and prostaglandin E2 levels in vitrectomy patients treated with ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1%. Retina. 2009 Oct;29(9):1310-3. doi: 10.1097/IAE.0b013e3181b094e6.
PubMed 19934822Ozturk BT, Bozkurt B, Kerimoglu H, Okka M, Kamis U, Gunduz K. Effect of serum cytokines and VEGF levels on diabetic retinopathy and macular thickness. Mol Vis. 2009 Sep 19;15:1906-14.
PubMed 19784389Hanifi-Moghaddam P, Kappler S, Seissler J, Muller-Scholze S, Martin S, Roep BO, Strassburger K, Kolb H, Schloot NC. Altered chemokine levels in individuals at risk of Type 1 diabetes mellitus. Diabet Med. 2006 Feb;23(2):156-63. doi: 10.1111/j.1464-5491.2005.01743.x.
PubMed 16433713Oh IK, Kim SW, Oh J, Lee TS, Huh K. Inflammatory and angiogenic factors in the aqueous humor and the relationship to diabetic retinopathy. Curr Eye Res. 2010 Dec;35(12):1116-27. doi: 10.3109/02713683.2010.510257.
PubMed 21121809Bressler NM, Edwards AR, Antoszyk AN, Beck RW, Browning DJ, Ciardella AP, Danis RP, Elman MJ, Friedman SM, Glassman AR, Gross JG, Li HK, Murtha TJ, Stone TW, Sun JK; Diabetic Retinopathy Clinical Research Network. Retinal thickness on Stratus optical coherence tomography in people with diabetes and minimal or no diabetic retinopathy. Am J Ophthalmol. 2008 May;145(5):894-901. doi: 10.1016/j.ajo.2007.12.025. Epub 2008 Feb 21.
PubMed 18294608
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT02646072
- Acronym / sponsor ID
- 20148-494
- Keywords
- diabetes mellitus, aqueous humor, inflammatory cytokines, cystoid macular edema, postoperative, nonsteroidal anti-inflammatory drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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.
The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.
Detailed description
To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.
To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus patients | Active comparator | Drug: Ketorolac tromethamine ophthalmic solution 0.45%Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery |
| Diabetes mellitus control patients | No intervention | –Topical refresh plus four times a day for 3 days prior to cataract surgery |
| Non diabetic patients | Active comparator | Drug: Ketorolac tromethamine ophthalmic solution 0.45%Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery |
| Non diabetic control patients | No intervention | –Topical refresh plus four times a day for 3 days prior to cataract surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diabetic patient group
- Type 2 diabetes mellitus with no diabetic retinopathy
- If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
- Listed for phacoemulsification cataract surgery
- Non diabetic patient group
Key exclusion criteria (5 listed)
- Smoker
- Presence of immune disease, local or systemic inflammation
- Presence of retinal diseases, glaucoma
- Previous surgical procedure on the eye
- Intra-operative complications
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 |
|---|---|---|
| Ketorolac tromethamine ophthalmic solution 0.45%Also: AcuvailIndicated for the treatment of pain and inflammation following cataract surgery. | Drug | Diabetes mellitus patients, Non diabetic patients |
Primary outcome
Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
Time frame: 9 months
Aqueous samples were analyzed at the same after complete samples collection.
1 secondary outcome
Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 22511846Cheung CM, Vania M, Ang M, Chee SP, Li J. Comparison of aqueous humor cytokine and chemokine levels in diabetic patients with and without retinopathy. Mol Vis. 2012;18:830-7. Epub 2012 Apr 4.
- Background: PubMed 23922491Dong N, Xu B, Wang B, Chu L. Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis. 2013 Aug 4;19:1734-46. Print 2013.
- Background: PubMed 24319335Chu L, Wang B, Xu B, Dong N. Aqueous cytokines as predictors of macular edema in non-diabetic patients following uncomplicated phacoemulsification cataract surgery. Mol Vis. 2013 Nov 24;19:2418-25. eCollection 2013.
- Background: PubMed 22094296Yilmaz T, Cordero-Coma M, Gallagher MJ. Ketorolac therapy for the prevention of acute pseudophakic cystoid macular edema: a systematic review. Eye (Lond). 2012 Feb;26(2):252-8. doi: 10.1038/eye.2011.296. Epub 2011 Nov 18.
- Background: PubMed 24264034Schoenberger SD, Kim SJ, Sheng J, Calcutt MW. Reduction of vitreous prostaglandin E2 levels after topical administration of ketorolac 0.45%. JAMA Ophthalmol. 2014 Feb;132(2):150-4. doi: 10.1001/jamaophthalmol.2013.5692.
- Background: PubMed 24336915Schoenberger SD, Kim SJ, Shah R, Sheng J, Cherney E. Reduction of interleukin 8 and platelet-derived growth factor levels by topical ketorolac, 0.45%, in patients with diabetic retinopathy. JAMA Ophthalmol. 2014 Jan;132(1):32-7. doi: 10.1001/jamaophthalmol.2013.6203.
- Background: PubMed 17720069Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550-8. doi: 10.1016/j.jcrs.2007.05.013.
- Background: PubMed 18165083Almeida DR, Johnson D, Hollands H, Smallman D, Baxter S, Eng KT, Kratky V, ten Hove MW, Sharma S, El-Defrawy S. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg. 2008 Jan;34(1):64-9. doi: 10.1016/j.jcrs.2007.08.034.
- Background: PubMed 18599019Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
- Background: PubMed 21992076Bucci FA Jr, Waterbury LD. A randomized comparison of to-aqueous penetration of ketorolac 0.45%, bromfenac 0.09% and nepafenac 0.1% in cataract patients undergoing phacoemulsification. Curr Med Res Opin. 2011 Dec;27(12):2235-9. doi: 10.1185/03007995.2011.626018. Epub 2011 Oct 12.
- Background: PubMed 19934822Heier JS, Awh CC, Busbee BG, Waterbury LD, Daniel P, Stoller GL, Cleary TS. Vitreous nonsteroidal antiinflammatory drug concentrations and prostaglandin E2 levels in vitrectomy patients treated with ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1%. Retina. 2009 Oct;29(9):1310-3. doi: 10.1097/IAE.0b013e3181b094e6.
- Background: PubMed 19784389Ozturk BT, Bozkurt B, Kerimoglu H, Okka M, Kamis U, Gunduz K. Effect of serum cytokines and VEGF levels on diabetic retinopathy and macular thickness. Mol Vis. 2009 Sep 19;15:1906-14.
- Individual participant dataSharing planned: Undecided
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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.
Yin Peng Lai, MOphthal principal investigator
University of Malaya
Mohammadreza Peyman, Mophthal study chair
University of Malaya
Tajunisah Iqbal, FRCS Ophth study director
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac tromethamine ophthalmic solution 0.45% in people with Cystoid Macular Edema, Postoperative and Diabetes Mellitus, run by University of Malaya at 1 site in Malaysia.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays (time frame: 9 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 NCT02646072, which also lists 16 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 5 Jan 2016.