Limbal Relaxing Incisions Versus Paired 4 mm Clear Corneal Incisions on Steep Meridian During Phacoemulsification

NCT05593263 | Unknown

• 1 other identifier: Soh-Med-22-10-17
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this is prospective, computer based randomized clinical trial is to compare the efficacy of reduction of the pre-existing corneal astigmatism at the time of cataract surgery in patients admitted in sohag university hospital. the main questions it aims to answer are :

• Is limbal relaxing incisions as effective as the paired opposite 4mm clear corneal incisions technique in reduction of corneal astigmatism at the time of cataract surgery ?
• Are both techniques effective in treating mild degrees of corneal Astigmatism ? All participants will have full ophthalmological examination necessary for routine cataract surgery, then randomly divided into 2 groups, clear corneal incision group \& limbal relaxing incision group. Researcher will compare difference between both groups regarding the following :
• Uncorrected distance visual acuity (UCVA)
• Best Corrected visual acuity (BCVA)
• keratometry readings

Conditions

Corneal Astigmatism

Keywords

astigmatism; limbal relaxing incisions; cataract surgery

Outcome Measures

Primary Outcomes (1)

• change of corneal astigmatism assessed by K readings measurment

  keratometry readings by autokeratometry, Topcon KR-8900, Tokyo, Japan ) confirmed by Pentacam (Sirius Scheimpflug Placido topography .CSO, Florence, Italy).

  1month post operative , 3 month post operative , 6 month post operative

Secondary Outcomes (1)

• change of manifest refraction assessed by autorefractometer (Topcon KR-8900, Tokyo,

  1month post operative , 3 month post operative , 6 month post operative

Study Arms (2)

Clear corneal incisions

EXPERIMENTAL

the Steep meridian will be identified and marked, One clear corneal incision will be made on one side of the steep axis using 2.4mm keratome knife then enlarged to 4mm after completion of cataract surgery \& other corneal 4mm incision is added to the other side of the steep axis

Procedure: surgical correction of astigmatism with cataract

Limbal relaxing incision

EXPERIMENTAL

Single or paired LRI will be performed on the steep axis prior to phaco-emulsification procedure using a 600 μm diamond guarded blade.

Procedure: surgical correction of astigmatism with cataract

Interventions

surgical correction of astigmatism with cataract PROCEDURE

The Steep meridian will be identified and marked, relaxing limbal / corneal incisions will be designed according to it.

Clear corneal incisions; Limbal relaxing incision

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract patients aged 21- 80 years.
• keratometric astigmatism 1D - 4D.
• Healthy clear cornea

You may not qualify if:

• History of previous keratorefractive or anterior segment surgery.
• Previous ocular trauma .
• Corneal scar or opacities.
• Irregular corneal astigmatism.
• Cataract unsuitable for phacoemulsification.
• Ongoing chronic ocular pathology

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of opthalmology

Model Details: Candidates will be randomly divided into two groups, OCCE group \& LRI group before their cataract surgery.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 25, 2022
• Study Start: November 15, 2022
• Primary Completion: November 15, 2023
• Study Completion: February 15, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10