Clinical trial NCT06896357: Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism
Official title: Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Astigmatism
Phacoemulsification
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Detailed description: Astigmatism is one of the commonest refractive errors encountered during our clinical practice. Surgically induced astigmatism is the main obstacle to achieve good uncorrected visual acuity following cataract surgery. It is estimated that corneal astigmatism of more than 1.0 diopter (D) is found in up to 40% of patients presenting for cataract surgery, 1.5D or more is present in over 20% and above 2.0D in 10%.

Astigmatism induces distortion of the image leading to compromise quality of vision. In order to achieve better visual results, the effect of postoperative astigmatism should be minimized, management options for corneal astigmatism include glasses, contact lenses, and surgery such as Limbal relaxing incisions (LRIs), refractive laser surgery, toric lenses or rarely corneal grafting. The LRIs technique involves the placement of incisions corresponding to the steep meridian, resulting in corneal flattening and the reduction of astigmatic power. LRI is a safe and an inexpensive procedure, which is simple for experts to perform. Although most of the nomograms recommended that LRIs technique can correct up to 3 D of astigmatism ,it has been found that it is possible to correct even more than 4 D if the incisions were performed on high degrees of astigmatism.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: visual acuity improvement
timeFrame: 3 months
measure: contrast sensitivity improvement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ehab Ismail Ahmed, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Hani Omar Elsodafy, Assistant Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Sara Hussein Mohamed, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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
citation: OAM SWJUJoO. Managing Corneal Astigmatism. 2023;11(03):78-82
citation: 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.
citation: 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.
citation: 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.
citation: 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.