Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05457348
Other study ID # Corneal incision & Astigmatism
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 30, 2022
Est. completion date March 2, 2023

Study information

Verified date July 2022
Source Suleman Roshan Medical College
Contact Jamshad Ahmed, FCPS
Phone 03332441746
Email jamshikhan1962@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a monofocal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism4. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide)


Description:

According to the 2020 estimate, 33·6 million adults aged 50 years and older were blind with cataracts as a leading cause (15·2 million cases). According to Pakistan national blindness survey, cataract is the leading cause of blindness in Pakistan. Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a mono-focal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide). Our study aims to compare the results of phacoemulsification cataract surgery with a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) with convention supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism. We hypothesize that a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) is better than conventional supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism at a significant level of 0.05.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date March 2, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: Cataract patients aged between 50 and 80 years having 1.0 diopters (D) or greater of regular corneal astigmatism documented by keratometry. Exclusion Criteria: 1. Previous ocular surgery. 2. previous ocular trauma. 3. Pre-existing ocular disease. 4. High intraocular pressure (IOP) 5. Corneal opacity. 6. Strabismus 7. Amblyopia 8. Diabetes mellitus 9. Irregular astigmatism. -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Planned incisions during phacoemulsification
Planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian will be performed in the experimental group during phacoemulsification

Locations

Country Name City State
Pakistan Suleman Roshan Medical College Hospital Tando Adam Sindh

Sponsors (1)

Lead Sponsor Collaborator
Suleman Roshan Medical College

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Day AC, Dhariwal M, Keith MS, Ender F, Perez Vives C, Miglio C, Zou L, Anderson DF. Distribution of preoperative and postoperative astigmatism in a large population of patients undergoing cataract surgery in the UK. Br J Ophthalmol. 2019 Jul;103(7):993-10 — View Citation

Dineen B, Bourne RR, Jadoon Z, Shah SP, Khan MA, Foster A, Gilbert CE, Khan MD; Pakistan National Eye Survey Study Group. Causes of blindness and visual impairment in Pakistan. The Pakistan national blindness and visual impairment survey. Br J Ophthalmol. — View Citation

GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION — View Citation

Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25. Review. — View Citation

Ren Y, Fang X, Fang A, Wang L, Jhanji V, Gong X. Phacoemulsification With 3.0 and 2.0 mm Opposite Clear Corneal Incisions for Correction of Corneal Astigmatism. Cornea. 2019 Sep;38(9):1105-1110. doi: 10.1097/ICO.0000000000001915. — View Citation

What is current GDP of Pakistan?. Paid for articles.com. naeemofficial3; Jun 19, 2022

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in Astigmatism Postoperative reduction in astigmatism after phacoemulsification. Patients will be assessed at first postoperative day then after one month , three months and six months.
See also
  Status Clinical Trial Phase
Completed NCT04432181 - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Completed NCT04844281 - Wear Experience With Daily Toric Contact Lenses Over a Long Day N/A