Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.

Sponsor

Suleman Roshan Medical College (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05457348

Collaborator

(none)

160

Enrollment

Location

Arms

7.1

Anticipated Duration (Months)

22.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Astigmatism of Both Eyes	Procedure: Planned incisions during phacoemulsification	N/A

Detailed 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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized into experimental and controlled groupsPatients will be randomized into experimental and controlled groups

Masking:

Single (Participant)

Masking Description:

The patient will be selected and randomized into two groups after obtaining informed consent. patient will not know about the intervention

Primary Purpose:

Treatment

Official Title:

Effect of Single Incision Versus Three Planned Incision to Reduce Pre-operative Astigmatism After Phacoemulsification.

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Mar 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A:experimental group those who receive planned incisions	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
Active Comparator: Group B:Controlled group the patients who were operated by conventional phacoemulsification	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

Arm

Intervention/Treatment

Experimental: Group A:experimental group

those who receive planned incisions

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

Active Comparator: Group B:Controlled group

the patients who were operated by conventional phacoemulsification

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

Outcome Measures

Primary Outcome Measures

Reduction in Astigmatism [Patients will be assessed at first postoperative day then after one month , three months and six months.]
Postoperative reduction in astigmatism after phacoemulsification.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suleman Roshan Medical College Hospital	Tando Adam	Sindh	Pakistan	68050

Sponsors and Collaborators

Suleman Roshan Medical College

Investigators

Principal Investigator: Jamshad Ahmed, FCPS, Suleman Roshan Medical College

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Jamshad Ahmed, Professor, Suleman Roshan Medical College

ClinicalTrials.gov Identifier:

NCT05457348

Other Study ID Numbers:

Corneal incision & Astigmatism

First Posted:

Jul 14, 2022

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jamshad Ahmed, Professor, Suleman Roshan Medical College

Astigmatism. phacoemulsification, corneal incision

Additional relevant MeSH terms:

Astigmatism

Surgical Wound

Study Results

No Results Posted as of Jul 14, 2022