AzTrials
AzTrials

CataractPhase 4NCT01832311

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

A Phase 4 study testing Ketorolac in people with Cataract and Type 2 Diabetes Mellitus, run by University of Zagreb at 2 sites in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cataract, Type 2 Diabetes Mellitus
What is being tested?
Ketorolac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
2 sitesCroatia
Study dates
Jan 2009to Dec 2012
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • patients undergoing phacoemulsification combined with IOL implantation
  • for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years
  • for diabetic group: therapy with oral hypoglycemic agents for glycemic control
  • no other ocular (retinal) or systemic diabetic complications of T2DM

Who cannot join

  • patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma
  • patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH)

Trial locations and contacts

2 sites in 1 country.

Croatia2 sites

  • Department of Ophtalmology, General Hospital "Dr. J. Bencevic"

    Slavonski Brod, Brod-Posavina County, 35000

  • Department of Physiology and Immunology, University of Zagreb School of Medicine

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

About this study

The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens surgery complications.

Read the detailed description

The study compared the levels of several immunoregulatory molecules (vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), Fas Ligand (FasL), interleukin-10 (IL-10) and interleukin-17 (IL-17)) in serum and aqueous humor between type 2 diabetes mellitus patients, without clinically evident diabetic retinopathy or diabetic macular edema, and nondiabetic cataract patients.

Investigators also investigated whether concentrations of immunoregulatory molecules significantly correlated with intraoperative and postoperative parameters. Particularly, investigators focused on the development of corneal edema as one of the main causes of low visual acuity in the immediate postoperative period after intraocular lens implantation.

Since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens (IOL) surgery complications, the findings may be relevant for the development of therapeutic strategies aimed to restore protein profile of immunoregulatory factors in parallel to cataract treatment.

Being tested
Ketorolac
Keywords
type 2 diabetes mellitus, cataract, cytokines, chemokines, aqueous humor
Medical subject headings
Cataract, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetorolacDrug

    Also called Toradol, Acular, Sprix

    Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.

Study groups in NCT01832311
Study groupRoleWhat they receive
senile cataract with NSAIDExperimental15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
Receives: Drug: Ketorolac
diabetic cataract with NSAIDExperimental17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
Receives: Drug: Ketorolac
senile cataract without NSAIDNo intervention17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.
diabetic cataract without NSAIDNo intervention12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum level of interleukin-10

    Measured: 2 hours before the surgery

  2. serum level of monocyte chemotactic protein-1

    Measured: 2 hours before the surgery

  3. serum level of interleukin-17

    Measured: 2 hours before the surgery

  4. serum level of Fas ligand

    Measured: 2 hours before the surgery

  5. serum level of vascular endothelial growth factor

    Measured: 2 hours before the surgery

  6. level of interleukin-10 in aqueous humor

    Measured: intraoperatively, at the start of the surgical procedure

  7. level of monocyte chemotactic protein-1 in aqueous humor

    Measured: intraoperatively, at the start of the surgical procedure

  8. level of interleukin-17 in aqueous humor

    Measured: intraoperatively, at the start of the surgical procedure

  9. level of Fas ligand in aqueous humor

    Measured: intraoperatively, at the start of the surgical procedure

  10. level of vascular endothelial growth factor in aqueous humor

    Measured: intraoperatively, at the start of the surgical procedure

Secondary outcomes (5)

  1. degree of corneal edema

    Measured: preoperatively - 2 hours before the surgery

  2. degree of corneal edema

    Measured: postoperatively - day 1

  3. degree of corneal edema

    Measured: postoperatively - day 8

  4. degree of corneal edema

    Measured: postoperatively - week 3

  5. degree of corneal edema

    Measured: postoperatively - month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2013 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2011
  4. Study completionDec 2012

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01832311
Sponsor's protocol ID
108-1080229-0142
Status last verified
Apr 2013
First submitted
5 Apr 2013
Last updated
16 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PubMed 15111519

  • Benson WE. Cataract surgery and diabetic retinopathy. Curr Opin Ophthalmol. 1992 Jun;3(3):396-400. doi: 10.1097/00055735-199206000-00015.

    PubMed 10149703

  • Klein BE, Klein R, Moss SE. Prevalence of cataracts in a population-based study of persons with diabetes mellitus. Ophthalmology. 1985 Sep;92(9):1191-6. doi: 10.1016/s0161-6420(85)33877-0.

    PubMed 4058882

  • Nielsen NV, Vinding T. The prevalence of cataract in insulin-dependent and non-insulin-dependent-diabetes mellitus. Acta Ophthalmol (Copenh). 1984 Aug;62(4):595-602. doi: 10.1111/j.1755-3768.1984.tb03972.x.

    PubMed 6385608

  • Hamilton AMP (1996) Epidemiology of Diabetic Retinopathy. In: Hamilton AMP, Ulbig MW, Polkinghorne P (eds) Management of Diabetic Retinopathy. B.M.J. Publishing Group, London, pp. 1-15

  • Obrosova IG, Minchenko AG, Vasupuram R, White L, Abatan OI, Kumagai AK, Frank RN, Stevens MJ. Aldose reductase inhibitor fidarestat prevents retinal oxidative stress and vascular endothelial growth factor overexpression in streptozotocin-diabetic rats. Diabetes. 2003 Mar;52(3):864-71. doi: 10.2337/diabetes.52.3.864.

    PubMed 12606532

  • Pollreisz A, Schmidt-Erfurth U. Diabetic cataract-pathogenesis, epidemiology and treatment. J Ophthalmol. 2010;2010:608751. doi: 10.1155/2010/608751. Epub 2010 Jun 17.

    PubMed 20634936

  • Funatsu H, Yamashita H, Noma H, Mimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2002 Jan;133(1):70-7. doi: 10.1016/s0002-9394(01)01269-7.

    PubMed 11755841

  • Gverovic Antunica A, Karaman K, Znaor L, Sapunar A, Busko V, Puzovic V. IL-12 concentrations in the aqueous humor and serum of diabetic retinopathy patients. Graefes Arch Clin Exp Ophthalmol. 2012 Jun;250(6):815-21. doi: 10.1007/s00417-011-1905-4. Epub 2012 Jan 8.

    PubMed 22227739

  • Jonas JB, Jonas RA, Neumaier M, Findeisen P. Cytokine concentration in aqueous humor of eyes with diabetic macular edema. Retina. 2012 Nov-Dec;32(10):2150-7. doi: 10.1097/IAE.0b013e3182576d07.

    PubMed 22617833

  • 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 22511846

  • Hernandez C, Segura RM, Fonollosa A, Carrasco E, Francisco G, Simo R. Interleukin-8, monocyte chemoattractant protein-1 and IL-10 in the vitreous fluid of patients with proliferative diabetic retinopathy. Diabet Med. 2005 Jun;22(6):719-22. doi: 10.1111/j.1464-5491.2005.01538.x.

    PubMed 15910622

  • Funatsu H, Yamashita H, Sakata K, Noma H, Mimura T, Suzuki M, Eguchi S, Hori S. Vitreous levels of vascular endothelial growth factor and intercellular adhesion molecule 1 are related to diabetic macular edema. Ophthalmology. 2005 May;112(5):806-16. doi: 10.1016/j.ophtha.2004.11.045.

    PubMed 15878060

  • Stefek M, Karasu C. Eye lens in aging and diabetes: effect of quercetin. Rejuvenation Res. 2011 Oct;14(5):525-34. doi: 10.1089/rej.2011.1170. Epub 2011 Oct 6.

    PubMed 21978083

  • Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6.

    PubMed 9917782

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac in people with Cataract and Type 2 Diabetes Mellitus, run by University of Zagreb at 2 sites in Croatia.

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 4 inclusion and 2 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 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Croatia. 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?

serum level of interleukin-10 (time frame: 2 hours before the surgery). The study lists 10 primary outcomes in all. 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 NCT01832311, which also lists 39 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 16 Apr 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in