NCT06896357

Brief Summary

To compare the effect of Limbal relaxing incisions (LRIs) plus spectacle correction versus spectacle correction alone on subjective and objective improvement in visual function for correcting post phacoemulsification high astigmatism .

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
1mo left

Started May 2025

Status
not yet recruiting

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 Progress94%
May 2025Jun 2026

First Submitted

Initial submission to the registry

March 17, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 17, 2025

Last Update Submit

March 24, 2025

Conditions

AstigmatismPhacoemulsification

Outcome Measures

Primary Outcomes (2)

  • visual acuity improvement

    assessment the improvement in visual acuity ,which will be measured by Landolt Cs chart with decimal notation.

    3 months

  • contrast sensitivity improvement

    Assessment the improvement in contrast sensitivity using Pelli-Robson contrast sensitivity test .

    3 months

Study Arms (1)

patients with post phacoemulsification high astigmatism .

EXPERIMENTAL
Procedure: Limbal relaxing incisions

Interventions

Limbal relaxing incisionsPROCEDURE

A fixed depth diamond-guarded knife (Gemcision LRI 600 Microns Blade, Katalyst Surgical, chesterfield, MO, USA) will be used to create a paired circumferential corneal incision, following the limbal curvature, 1-1.5mm anterior to the limbus centered on the steep corneal meridian. The incision arc length will be ninety degree according to the Nichamin Age and Pachymetry Adjusted (NAPA) nomogram.

patients with post phacoemulsification high astigmatism .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conventional phacoemulsification was done at least one month earlier.
  • Clear cornea with corneal astigmatism more than 3.0 D.

You may not qualify if:

  • History of corneal surgeries (e.g., keratoplasty, refractive surgery, and corneal wound repair).
  • Ocular trauma.
  • Other intraocular surgery.
  • Patient with corneal opacities.
  • Thin cornea .
  • Any significant ocular disease causing diminution of vision (e.g., optic atrophy, diabetic retinopathy, and age-related macular degeneration), autoimmune disease, and peripheral corneal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Li Z, Han Y, Hu B, Du H, Hao G, Chen X. Effect of Limbal relaxing incisions during implantable collamer lens surgery. BMC Ophthalmol. 2017 May 8;17(1):63. doi: 10.1186/s12886-017-0458-7.

    PMID: 28482825BACKGROUND

  • Rashwan A, Natag A, Wasfi E, Lotfy H, Shehata MJDJoO. Manually performed limbal relaxing incisions versus femtosecond laser-guided astigmatic keratotomy for correction of corneal astigmatism after phacoemulsification. 2024;25(3):150-5

    BACKGROUND

  • OAM SWJUJoO. Managing Corneal Astigmatism. 2023;11(03):78-82

    BACKGROUND

  • Khan MI, Muhtaseb M. Prevalence of corneal astigmatism in patients having routine cataract surgery at a teaching hospital in the United Kingdom. J Cataract Refract Surg. 2011 Oct;37(10):1751-5. doi: 10.1016/j.jcrs.2011.04.026. Epub 2011 Aug 12.

    PMID: 21840163BACKGROUND

  • Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg. 2009 Jan;35(1):70-5. doi: 10.1016/j.jcrs.2008.09.027.

    PMID: 19101427BACKGROUND

  • Theiss MB, Santhiago MR, Moraes HV Jr, Gomes BF. Prevalence of corneal astigmatism in cataract surgery candidates at a public hospital in Brazil. Arq Bras Oftalmol. 2019 Jun 3;82(5):377-380. doi: 10.5935/0004-2749.20190071.

    PMID: 31166427BACKGROUND

  • Khoramnia R, Auffarth G, Labuz G, Pettit G, Suryakumar R. Refractive Outcomes after Cataract Surgery. Diagnostics (Basel). 2022 Jan 19;12(2):243. doi: 10.3390/diagnostics12020243.

    PMID: 35204334BACKGROUND

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ehab Ismail Ahmed, Professor

    Assiut University

    STUDY CHAIR

  • Hani Omar Elsodafy, Assistant Professor

    Assiut University

    STUDY CHAIR

  • Sara Hussein Mohamed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

youstina shaheir gad, resident doctor

CONTACT

+2088234-1993youstina.shaheir22@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor of ophthalmology

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 26, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share