NCT06904404

Brief Summary

The goal of this clinical trial is to investigate the early post-operative benefits of performing phacoemulsification at physiologic intraocular pressures. The main questions it aims to answer are:

  • Is there less post operative corneal edema?
  • Is there less post operative inflammation?
  • Is the post operative vision better? Participants will undergo phacoemulsification cataract surgery with either high or low IOP settings Researchers will compare post op corneal edema, inflammatory marker levels and vision

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

March 24, 2025

Results QC Date

July 7, 2025

Last Update Submit

July 28, 2025

Conditions

Cataract

Keywords

phacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Change in Early Post Operative Central Corneal Thickness

    4 hours post operatively central corneal thickness assessment

    4 hours post operatively

Secondary Outcomes (1)

  • IL-IB From Aqueous Sample

    2 minutes after cataract surgery completion

Study Arms (2)

High IOP setting

Traditional High (65mm Hg) IOP phacoemulsification settings

Procedure: Cataract surgery at high IOP

Low IOP Setting

Physiologic Low (20 mm Hg) IOP phacoemulsification settings

Procedure: Cataract surgery at low IOP

Interventions

Cataract surgery at high IOPPROCEDURE

Cataract surgery at high IOP (conventional)

High IOP setting
Cataract surgery at low IOPPROCEDURE

Cataract surgery at low IOP

Low IOP Setting

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Visually significant cataract patients with no prior history of cataract surgery

You may qualify if:

  • Patients without prior ocular surgery both eyes
  • Adult patients with visually significant cataract with WHO-World Health Organization NUC grade 2-3
  • First eye only undergoing uncomplicated cataract surgery
  • Unremarkable systemic history; controlled diabetes with HbA1c \<7%
  • Unremarkable ocular health
  • Anterior chamber depth ACD \>2.04mm10
  • Age range 55-95

You may not qualify if:

  • Prior ocular surgery including corneal refractive surgery, cataract surgery in fellow eye
  • Thin corneas (\<490 microns)
  • Complicated (use of pupil expansion devices) or prolonged cataract surgeries (\>15 mins) with post-operative complications (IOP spike \>30mmHg), severe punctate keratitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfe Eye Clinic Cedar Rapids (Hiawatha)

Hiawatha, Iowa, 52233, United States

Location

Related Publications (9)

  • Cyril D, Brahmani P, Prasad S, Rashme VL, R S, Kamble NR, Balakrishnan L, Nagu K, Shekhar M. Comparison of two phacoemulsification system handpieces: prospective randomized comparative study. J Cataract Refract Surg. 2022 Mar 1;48(3):328-333. doi: 10.1097/j.jcrs.0000000000000769.

    PMID: 34371511BACKGROUND

  • Vasavada AR, Praveen MR, Vasavada VA, Vasavada VA, Raj SM, Asnani PK, Garg VS. Impact of high and low aspiration parameters on postoperative outcomes of phacoemulsification: randomized clinical trial. J Cataract Refract Surg. 2010 Apr;36(4):588-93. doi: 10.1016/j.jcrs.2009.11.009.

    PMID: 20362850BACKGROUND

  • Lundberg B, Jonsson M, Behndig A. Postoperative corneal swelling correlates strongly to corneal endothelial cell loss after phacoemulsification cataract surgery. Am J Ophthalmol. 2005 Jun;139(6):1035-41. doi: 10.1016/j.ajo.2004.12.080.

    PMID: 15953433BACKGROUND

  • Suzuki H, Igarashi T, Takahashi H. Effect of a new phacoemulsification and aspiration handpiece on anterior chamber stability. J Cataract Refract Surg. 2023 Jan 1;49(1):91-96. doi: 10.1097/j.jcrs.0000000000001071.

    PMID: 36201661BACKGROUND

  • Kaup S, Pandey SK. Cataract surgery in patients with Fuchs' endothelial corneal dystrophy. Community Eye Health. 2019;31(104):86-87. No abstract available.

    PMID: 31086438BACKGROUND

  • Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6.

    PMID: 30528516BACKGROUND

  • De Maria M, Iannetta D, Cimino L, Coassin M, Fontana L. Measuring Anterior Chamber Inflammation After Cataract Surgery: A Review of the Literature Focusing on the Correlation with Cystoid Macular Edema. Clin Ophthalmol. 2020 Jan 9;14:41-52. doi: 10.2147/OPTH.S237405. eCollection 2020.

    PMID: 32021067BACKGROUND

  • Schultz T, Joachim SC, Kuehn M, Dick HB. Changes in prostaglandin levels in patients undergoing femtosecond laser-assisted cataract surgery. J Refract Surg. 2013 Nov;29(11):742-7. doi: 10.3928/1081597X-20131021-03.

    PMID: 24203805BACKGROUND

  • Feng MT, Belin MW, Ambrosio R Jr, Grewal SP, Yan W, Shaheen MS, McGhee C, Maeda N, Neuhann TH, Burkhard Dick H, Alageel SA, Steinmueller A. Anterior chamber depth in normal subjects by rotating scheimpflug imaging. Saudi J Ophthalmol. 2011 Jul;25(3):255-9. doi: 10.1016/j.sjopt.2011.04.005. Epub 2011 Apr 30.

    PMID: 23960933BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Edward Hu
Organization
Wolfe Eye Clinic
ehu@wolfe.com
(319) 362-8032

Study Officials

  • Edward H Hu, MD PhD

    Wolfe Eye Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 1, 2025

Study Start

January 1, 2024

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

August 12, 2025

Results First Posted

August 12, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)